MICHELANGELO: OASIS 5 (UA/NSTEMI)
An international randomized double-blind study
evaluating the efficacy and safety of fondaparinux versus enoxaparin
in the acute treatment of unstable angina / non ST-segment elevation MI
191 Croatia
Canadian Cardiovascular Collaboration (CCC) Project Office
Population Health Research InstituteHGH - McMaster Clinic, 237 Barton Street EastHamilton, Ontario
Sanofi-Synthelabo Recherche1, avenue Pierre Brossolette91385 Chilly Mazarin CedexFrance
FAX CASE REPORT FORMS TO DATAFAX: 0 800 22 0112 WSC 6004 Study Nnmber: 135 Do NOT fax this page. MICHELANGELO: ELIGIBILITY FORM DataFax #135 Plate #100 Visit #001 Croatia 191 Note: Patient ID will be provided by randomization service A. INCLUSION CRITERIA
( Must be ‘Yes’ to 1 and 2 and 3):
1. Ischemic chest pain/ischemic symptoms occurring at rest or with minimal activity
(> 5 minutes or requiring sublingual nitroglycerin for relief of pain)
2. Able to randomize within 24 hours of the onset of the most recent episode of symptoms
3. At least two of the following three criteria are met (please specify):
c) ECG changes compatible with ischemia (i.e., at least one of the following:)
ST depression > 1 mm in 2 contiguous leads
B. EXCLUSION CRITERIA (must be ‘No’ to all):
2. Any contraindication to low molecular weight heparin
3. Hemorrhagic stroke within the last 12 months
4. Indication for anticoagulation other than ACS
5. Pregnancy or women of childbearing potential who are not using an
6. Co-morbid condition with life expectancy less than 6 months
7. Prior enrollment in one of the fondaparinux ACS trials or currently
receiving an experimental pharmacologic agent
8. Revascularization procedure already performed for the qualifying event
9. Severe renal insufficiency (i.e. serum creatinine > 3 mg/dL or 265 µmol/L)
If all eligibility criteria are met, proceed to CRF 2. This form must be faxed to the CCC Project Office within 24 - 48 hours of randomization. MICHELANGELO: OASIS 5 RANDOMIZATION FORM DataFax #135 Plate #002 Visit #001 Croatia 191 A. ELIGIBILITY ASSESSMENT: Before calling the Randomization Service, complete the following with an X: Applies only to those countries participating in one of these substudies
All eligibility criteria met (CRF 1)
Blood drawn for admission laboratory tests
2. Patient’s weight in kilograms (required for weight-adjusted enoxaparin or enoxaparin-placebo):
3. Clinical diagnosis at the time of randomization (mark one only):
B. TREATMENT ALLOCATION: PLEASE CALL THE RANDOMIZATION SERVICE: 0 800 22 0112 WSC 6003 Study Number: 135 THE 24-HOUR RANDOMIZATIONSERVICE WILL PROVIDE THE FOLLOWING INFORMATION:
2. Patient ID Number: Record this number at the top of both CRFs 1 and 2 and all subsequent CRFs for this patient.
3. Treatment Number for both study drug preparations Affix Label from Record here as assigned by randomization service: Patient’s Treatment
a)Give initial dose of enoxaparin/enoxaparin-placebo 1 mg/kg subcutaneously
b) Give initial dose of study drug fondaparinux/fondaparinux-placebo 2.5 mg sc Note: Follow the study regimen described on Pocket Card and in the Investigator’s Manual 4. Has this patient been randomized to one of the catheterization substudies? This form must be faxed to the CCC Project Office within 24-48 hours of randomization. MICHELANGELO: OASIS 5 BASELINE FORM PAGE 1 OF 2 DataFax #135 Plate #003 Visit #002 Croatia 191 CLINICAL ASSESSMENT: Blood Label # Affix Specimen Collection Barcoded Label here
analysis:(Selected countries only)
6. Check if additional bloods will be drawn for biomarker substudy at 6 hrs, 24 hrs and 72 hrs. If Checked, complete
7. BASELINE ECG:
a) ECG (give most significant code from facing page for both type & location) If ‘9’, specify: If ‘9’, specify:
b) ECG Rhythm:(give most significantIf ‘9’, specify: ADMISSION LABORATORY TESTS: Provide results for the initial value for all tests done if available; mark others ‘ND’ (not done) Upper Limit of Normal Fax this form to the CCC Project Office within 3 days of randomization MICHELANGELO: OASIS 5 BASELINE FORM PAGE 2 OF 2 DataFax #135 Plate #004 Visit #002 Croatia 191 HISTORY:
Other objective evidence (specify):
12. Smoker: (mark [x] one box only)
13. Other Recreational Drug used within last 12 months: (mark [x] all that apply) Provide date and time only if drug was last used within previous PATIENT INFORMATION: mark [x] units If ’11’, specify:
4. Employment status: (mark [x] one box only)
over the course of the subject’s working life
If ‘10’, specify: Fax the Baseline Form to the CCC Project Office within 3 days of randomization MICHELANGELO: OASIS 5 HOSPITAL DISCHARGE VISIT - PAGE 1 OF 3 DataFax #135 Plate #005 Visit #003 Croatia 191 HOSPITAL DISCHARGE:(Transfer to acute care facility should be included in the initial hospitalization) (mark [X] only one box)
Transferred to long-term care/rehabilitation
CATHETERIZATION SUBSTUDY: If this patient is enrolled in either catheterization substudy complete CRF 7C CLINICAL EVENTS SINCE RANDOMIZATION : If Yes, complete report: Complete Death Report Complete Associated MI Report CRF 7A Report No.(s) Complete MI Report , # Refractory/Severe Ischemia Report CRF 7B Complete Stroke Report , # Complete Bleeding , # Report CRF 75 Complete SAE Report CRF 70 # , # Complete SAE CRF 70 , #
10. Has patient experienced any other relevant untoward medical event?
Report below Date of onset Permanent discontinuation of study drug (if Yes, report on CRF 7 question 4 and 5) Fax this form to the CCC Project Office within 3 days of hospital discharge MICHELANGELO: OASIS 5 HOSPITAL DISCHARGE VISIT PAGE 2 OF 3 DataFax #135 Plate #006 Visit #003 Croatia 191 Within 7 Days Prior During Initial Randomization Hospitalization Discharge CONCOMITANT MEDICATIONS: Fax this form to the CCC Project Office within 3 days of hospital discharge
- HOSPITAL DISCHARGE VISIT- Page 2 of 3 -
MICHELANGELO: OASIS 5 HOSPITAL DISCHARGE VISIT 3 OF 3 DataFax #135 Plate #007 Visit #003 Croatia 191 INTERVENTIONS SINCE RANDOMIZATION: if YES, completeCRF 7E Complete CRF 15 Complete CRF 16A &B # Complete CRF 17 STUDY DRUG ADMINISTRATION Mark [X] all doses of both study drugs administered after randomization. 1. Enoxaparin/Enoxaparin-Placebo 2. Fondaparinux/Placebo twice daily sc injections once daily sc injection 1st Dose 2nd Dose 1st Dose 2nd Dose 3. Was study drug given according to allocation at randomization?
If No, record incorrect Treatment Number given 4. Early permanent discontinuation of Enoxaparin/Placebo Reason If ‘9’ specify: 5. Early permanent discontinuation of Fondaparinux/Placebo
Yes Reason If ‘9’ specify: 6. How will most of the patient’s hospitalization costs be covered? (mark [x] all that apply) (Ensure that original 7. Date of next scheduled visit: target visit schedule is (30 days from randomization date) maintained at next visit) Fax this form to the CCC Project Office within 3 days of hospital discharge MICHELANGELO: ASSOCIATED MI REPORT DataFax #135 Plate #031 Visit #003 Croatia 191 Use this page to report only Myocardial Infarction associated with presenting symptoms at study entry. Associated MI is defined as: an MI associated with presenting symptoms initially diagnosed on admission as ACS (unstable angina or MI without ST segment elevation) with subsequent rise in cardiac enzymes or persistent ECG changes such that the diagnosis becomes an MI. 1. CHEST PAIN: Was there characteristic ischemic chest pain lasting longer than 20
minutes or other ischemic symptoms leading to randomization?
2. ECG: a) Was there subsequent ECG evidence of myocardial
infarction associated with presenting symptoms?
If YES, record details of ECG with most significant changes below:
d) Type of ECG change:(Record most significant code from facing page)(If ‘9’, specify):
e) Main ECG location: (Record most significant code from facing page)(If ‘9’, specify): 3. CARDIAC ENZYMES (Include initial and peak values of 2 cardiac enzymes or markers related to this episode) (check only one) a) Cardiac enzyme or Upper Limit of Normal (check only one) b) Other Cardiac enzyme or marker: Upper Limit of Normal Fax this form to the Project Office within 48 hours of diagnosis. MICHELANGELO: OASIS 5 REFRACTORY/SEVERE ISCHEMIA DURING INITIAL HOSPITALIZATION CRF 7B DataFax #135 Plate #032 Visit #003 Croatia 191 REPORT ALL EPISODES OF REFRACTORY AND/OR SEVERE ISCHEMIA (i.e. must have ECG evidence of ischemia) DURING INITIAL HOSPITALIZATION Refractory Ischemia = recurrent chest pain (> 5 min) + on optimal therapy + new ischemic ECG changes + or transfer for procedure within 48 hrs of symptom onset intervention Severe Ischemia = episode of chest pain (> 5 min) + on optimal therapy + new ischemic ECG changes SOURCE DOCUMENTATION REQUIRED FOR REFRACTORY ISCHEMIA: Baseline and subsequent ECGs with evidence of new ischemia, OR/Procedural Report, progress notes, consultant’s report or discharge summary. Fax this form to the CCC Project Office within 48 hours of hospital discharge.
- REFRACTORY/SEVERE ISCHEMIA (INITIAL HOSPITALIZATION) -
MICHELANGELO: OASIS 5 CATHETERIZATION SUBSTUDY REPORT Revised CRF 7C DataFax #135 Plate #107 Visit #003 Croatia 191 Complete this CRF ONLY for those patients randomized to one of the Catherization Substudies (Timing of Intervention or Women’s performed in select countries ONLY) All in-hospital procedures must be reported on CRF 7 with details of the procedure recorded on the appropriate study intervention CRFs 15, 16 and/or 17 whether or not they are associated with the catheterization substudy. 1. This patient has been randomized to:
Timing of Intervention Catheterization Substudy
Complete Section A Complete Section B A. TIMING OF INTERVENTION CATHETERIZATION SUBSTUDY
b) Was coronary angiography performed according to the randomization?
i) In patients randomized to early angiography, indicate whether angiography was Delayed
or Not Done
and state most significant reason: (see facing page for codes)If ‘17’,specify: If ‘17’,specify:
ii) In patients randomized to delayed angiography, indicate whether angiography was performed Early
or Not Done
and state most significant reason: (see facing page for codes)If ‘17’,specify: If ‘17’,specify: B. WOMEN’S CATHETERIZATION SUBSTUDY
Date and time of angiography if performed:
b) Was coronary angiography performed according to the randomization?
i) If patient randomized to invasive arm, state most significant reason why angiography not performed: Reason: (see facing page for codes) If ‘17’,specify: non-invasive arm, state most significant reason why angiography performed: Reason: (see reverse for codes) If ‘17’,specify:
c) Has patient completed Quality of Life Questionnnaires?
(mark [x] all that apply ) SAQ ( CRFs 300 - 302) EQ5D ( CRFs 200 - 202) SF-36v ( CRFs 400 - 404) Fax this form to the CCC Project Office within 48 hours of hospital discharge. MICHELANGELO: OASIS 5 BIOMARKER SUBSTUDY DataFax #135 Plate #108 Visit #003 Croatia 191 ADDITIONAL BLOOD SAMPLES FOR BIOMARKER SUBSTUDY 1. Was blood drawn for central analysis at 6 hours post-randomization? Blood Label # Affix Specimen Collection Barcoded Label here 2. Was blood drawn for central analysis at 24 hours post-randomization? Blood Label # Affix Specimen Collection Barcoded Label here 3. Was blood drawn for central analysis at 72 hours post-randomization? Blood Label # Affix Specimen Collection Barcoded Label here Fax this form to the CCC Project Office within 3 days of completion MICHELANGELO: INTERVENTION TRANSFER REPORT DataFax #135 Plate #109 Visit #003 Croatia 191 This form is only to be completed for patients transferred to another centre for Angiography, PCI or CABG. A. INTERVENTIONS PERFORMED AT CATHETERIZATION CENTRE B. CATHETERIZATION CENTRE INFORMATION If Centre No. not available please complete the following: Date of Transfer Date of Discharge/Transfer from Randomizing Centre from your centre
Transferred to long-term care/rehabilitation
Was study drug administered as per protocol?
Was study drug re-started after procedure(s)?
C. EVENTS AT CATHETERIZATION CENTRE
If an event* occurs while at the Catheterization Centre, please inform the Randomizing Centre immediately,and please provide supporting documentation to the Randomizing Centre as soon as possible.
*Serious Adverse Events (SAE) (definition on reverse page) must be reported to the coordinating office (CCCPO)within 24 hours of occurence. Therefore, notify the Randomizing Centre immediately, and forward the supportingdocumentation to the Randomizing Centre within 24 hours of the event onset.
This form must be returned to the Randomizing Centre within 24 - 48 hours of transfer. MICHELANGELO: OASIS 5 30 DAY FOLLOW-UP - Page 1 of 2 DataFax #135 Plate #008 Visit #004 Croatia 191 30 DAY FOLLOW-UP VISIT:
1. How were these follow-up data obtained? (Office follow-up is recommended for all patients)
Readmitted to hospital after initial event
CLINICAL EVENTS AFTER HOSPITAL DISCHARGE: If Yes, complete report: Complete Death Report CRF 99 Report No.(s) Complete MI Report CRF 30 , # Complete Rehospitalization for Unstable Angina , # Report CRF 50 Complete Stroke , # Report CRF 40 Complete Other Hospitalization Report CRF 55 , # Complete Bleeding , # Report CRF 75 Complete SAE Report CRF 70 , # Complete SAE Report CRF 70 , #
12. Has patient experienced any other relevant untoward medical event?
Report below Date of onset Fax this form to the CCC Project Office within 3 days of follow-up MICHELANGELO: OASIS 5 30 DAY FOLLOW-UP - Page 2 of 2 DataFax #135 Plate #009 Visit #004 Croatia 191 After Hospital After Hospital CONCOMITANT MEDICATIONS: Discharge Discharge INTERVENTIONS AFTER HOSPITAL DISCHARGE: Report No.(s) If Yes, complete report: Complete CRF 15 , # Complete CRF 16 A &B # , # Complete CRF 17 , # LIFESTYLE MODIFICATION:
If No, go to
b) Has the patient used any aids for smoking cessation in the last 30 days?
c) Has patient been advised about smoking cessation at this visit?
2. a) Is the patient currently enrolled in a cardiac rehabilitation program?
b) Is the patient exercising regularly (>30 min 3 times/ week)?
c) Has patient received counselling for dietary modification?
FOLLOW-UP: (Ensure that original target visit schedule is maintained at next visit) Fax this form to the CCC Project Office within 3 days of follow-up MICHELANGELO: OASIS 5 90 DAY FOLLOW-UP - Page 1of 2 DataFax #135 Plate #010 Visit #005 Croatia 191 90 DAY FOLLOW-UP VISIT:
1. How were these follow-up data obtained? (Office follow-up is recommended for all patients)
Readmitted to hospital after initial event
CLINICAL EVENTS SINCE LAST VISIT: If Yes, complete report: Complete Death Report CRF 99 Report No.(s) Complete MI Report CRF 30 , # Complete Rehospitalization for Unstable Angina , # Report CRF 50 Complete Stroke , # Report CRF 40 Complete Other Hospitalization , # Report CRF 55 Complete Bleeding , # Report CRF 75 Complete SAE Report CRF 70 , # Complete SAE Report CRF 70 , #
12. Has patient experienced any other relevant untoward medical event?
Report below Date of onset Fax this form to the CCC Project Office within 3 days of follow-up MICHELANGELO: 90 DAY FOLLOW-UP - Page 2 of 2 DataFax #135 Plate #011 Visit #005 Croatia 191 CONCOMITANT MEDICATIONS: Last Visit Last Visit INTERVENTIONS SINCE LAST VISIT: No Report No.(s) If Yes, complete report: Complete CRF 15 , # Complete CRF 16 A&B # , # Complete CRF 17 , # LIFESTYLE MODIFICATION:
If No, go to
Has the patient used any aids for smoking cessation in the last 30 days?
c) Has patient been advised about smoking cessation at this visit?
a) Is the patient currently enrolled in a cardiac rehabilitation program?
b) Is the patient exercising regularly (>30 min 3 times/ week)?
c) Has patient received counselling for dietary modification?
FOLLOW-UP: (Ensure that original target visit schedule is maintained at next visit) Fax this form to the CCC Project Office within 3 days of follow-up MICHELANGELO: OASIS 5 180 DAYS or FINAL FOLLOW-UP - Page 1 of 2 DataFax #135 Plate #012 Visit #006 Croatia 191 180 DAY or FINAL FOLLOW-UP VISIT:
1. How were these follow-up data obtained? (Office follow-up is recommended for all patients)
Readmitted to hospital after initial event
CLINICAL EVENTS SINCE LAST VISIT: If Yes, complete report: Complete Death Report CRF 99 Report No.(s) Complete MI Report CRF 30 , # Complete Rehospitalization for Unstable Angina , # Report CRF 50 Complete Stroke , # Report CRF 40 Complete Other Hospitalization Report CRF 55 , # Complete Bleeding Report CRF 75 , # Complete SAE Report CRF 70 (if considered major bleeding) , # Complete SAE Report CRF 70 , #
12. Has patient experienced any other relevant untoward medical event?
Report below Date of onset Fax this form to the CCC Project Office within 3 days of follow-up MICHELANGELO: 180 DAYS or FINAL FOLLOW-UP - Page 2 of 2 DataFax #135 Plate #013 Visit #006 Croatia 191 CONCOMITANT MEDICATIONS: Last Visit Last Visit INTERVENTIONS SINCE LAST VISIT: If Yes, complete report: Report No.(s) Complete CRF 15 , # Complete CRF 16 A&B# , # Complete CRF 17 , # LIFESTYLE MODIFICATION:
If No, go to
b) Has the patient used any aids for smoking cessation in the last 30 days?
c) Has patient been advised about smoking cessation at this visit?
a) Is the patient currently enrolled in a cardiac rehabilitation program?
b) Is the patient exercising regularly (>30 min 3 times/ week)?
c) Has patient received counselling for dietary modification?
FINAL FOLLOW-UP: CRF 14 (Study Completion/Investigator’s Statement) completed: Fax this form to the CCC Project Office within 3 days of follow-up MICHELANGELO: STUDY COMPLETION / INVESTIGATOR’S FINAL STATEMENT DataFax #135 Plate #014 Visit #006 Croatia 191
1. Has the patient completed the final follow-up visit?
Refer to Contact Form CRF 20
2. Was the study drug unblinded at any time during the study?
Please ensure that all supporting documents for all events for this patient have been sent to the CCC Project Office. I have reviewed the case report forms for this patient. To the best of my knowledge, the information collected is complete and accurate. Fax this form to the CCC Project Office within 48 hours of completion
- STUDY COMPLETION INVESTIGATOR’S FINAL STATEMENT-
MICHELANGELO: CORONARY ANGIOGRAPHY REPORT DataFax #135 Plate #015 Croatia 191 Complete one report for each coronary angiography procedure performed on this patient
2. Indication for coronary angiography: (mark [X] one box only)
b) Check culprit lesion(s) if applicable
Record percent stenosis in ALL vessels Complete section c) ONLY for those patients with previous CABG surgery
c) Check culprit lesion(s) if applicable
Record percent stenosis in ALL grafts Quantitative Assessment Qualitative Assessment (mark [X] one box only)
Mild impairmentModerate impairmentSevere impairment
4. Did the results of the coronary angiography lead to a revascularization procedure?
Provide most significant reason below: (mark [X] one box only) Fax this form to the CCC Project Office within 48 hours of procedure MICHELANGELO: PCI REPORT - Page 1 of 2 DataFax #135 Plate #116 Croatia 191
2. Indication for percutaneous coronary intervention: ( mark [X] one box only)
3. Was PCI performed during initial hospitalization and within 8 days of randomization?
a) Date of last fondaparinux/placebo injection prior to PCI:
b) Date of last enoxaparin/placebo injection prior to PCI:
c) Was catheter flushed with heparinized saline before insertion into patient?
d) Indicate Contrast Media used during PCI
e) First dose of fondaparinux/placebo given during PCI:
g) Was additional dose of study drug (anticoagulant) from PCI kit given during PCI?
4. Were open-label (non-study) anticoagulants/antithrombins administered? non-study Dose of UFH: Reason for UFH: Bivalirudin
5. Was a GPIIb/IIIa receptor antagonist given during PCI?
Upfront Specify If YES Date started
6. Was a thienopyridine given prior to PCI?
Specify Fax this form to the CCC Project Office within 48 hours of procedure MICHELANGELO: OASIS 5 PCI REPORT - Page 2 of 2 DataFax #135 Plate #117 Croatia 191
1. PCI Procedure Chart to be completed for each PCI performed at this sitting:
Angiographic Max Stenosis Thrombus Location see reverse 1=Yes,Bare Stent see reverse 2=Yes, for codes for codes Procedure
7. Were there any vascular site complications of PCI?
Complete Bleeding Report CRF 75
8. Were there any other complications during PCI?
If Yes, complete a) to d) mark [x] all that apply
Open-label (non-study) anticoagulants/antithrombins given as a result of PCI complication(s): (mark [x] all that apply) dose dose non-study dose Bivalirudin Other(specify): (mark [x] all that apply) (Complete CRF 99) (Complete CRF 30) (Complete CRF 40)
9. Was study drug fondaparinux/placebo restarted
(If Yes, provide date and time drug restarted)
10. Was study drug enoxaparin/placebo restarted
(If Yes, provide date and time drug restarted) Fax this form to the CCC Project Office within 48 hours of procedure MICHELANGELO: CABG SURGERY REPORT DataFax #135 Plate #018 Croatia 191 Complete one report for each procedure performed on this patient Mark [X] all Mark [X] all Mark [X] all Mark [X] all that apply
grafts Other Arterial Complete Bleeding Report CRF 75
7. a) Transfusions during 1st 24 hours post-op:
b) Total Chest tube bleeding within 1st 24 hours post-op:
8. Was patient taking study drug within 24 hours prior to CABG surgery?
Mark [x] all that apply
9. Was patient taking any antithrombotic medications
10. Was study drug restarted after CABG surgery?
Fax this form to the CCC Project Office within 48 hours of CABG Surgery MICHELANGELO: DataFax #135 Plate #020 Croatia 191 USE THIS PAGE ONLY FOR THOSE PATIENTS WHO DID NOT COMPLETE FINAL FOLLOW-UP VISIT Continue to try to make contact as per instructions.
Other qualified professional (specify):
5. Who was contacted? (check all that apply)
patient’s relative (relationship):
6. Did patient experience any one of the following since last visit?
If the response to any of the questions above is YES or NO, please complete final follow-up visit CRFs documenting the patient status as of the scheduled final visit date. Fax this form to the CCC Project Office within 48 hours of completion MICHELANGELO: MI REPORT DataFax #135 Plate #030 Croatia 191
1. Date of onset of Myocardial Infarction:
4. Elevation of Cardiac Enzymes or markers consistent with myocardial infarction (Include initial and peak values of 2 cardiac Total CK CK-MB enzymes or markers relatedto this episode) a) Cardiac enzyme or marker: (check only one) Upper Limit of Normal (check only one) b) Other Cardiac enzyme or marker: Upper Limit of Normal 5. Did patient experience ischemic symptoms? 6. Were there ECG changes consistent ischemia? If Yes, Date and Time of ECG
Provide details of ECG with most diagnostic changes:
(If ‘9’, specify): (If ‘9’, specify): Complete Death Report CRF 99 Fax this form to the CCC Project Office within 48 hours of event. MICHELANGELO: STROKE REPORT DataFax #135 Plate #040 Croatia 191
If Yes, Admission Date: 4. SYMPTOMS:( Mark [X] all symptoms present for >= 24 hours)
c) Ocular or visual symptoms (e.g. amaurosis fugax)
5. STATUS: (select single best description at 7 days or discharge, whichever is earliest, after stroke onset)
e) Patient incapacitated, unable to perform
c) Some functional impairment but patient
Complete Death Report 6. BODY SIDE/VISUAL FIELD AFFECTED: (Mark [X] all that apply) 7. TREATMENT: Mark [x] all that apply
a) Was the patient on any antithrombotic medications
b) Did the patient undergo an invasive procedure
within the 24 hours prior to onset of stroke- symptoms?
8. DIAGNOSTIC TESTS:
Was CT Scan/MRI done to confirm diagnosis?
Yesspecify 9. FINAL DIAGNOSIS: Mark [X] one box only
(definite confirmed by CT, MRI or autopsy)
Fax this form to the CCC Project Office within 48 hours of event. MICHELANGELO: OASIS 5 REHOSPITALIZATION FOR UNSTABLE ANGINA DataFax #135 Plate #050 Croatia 191 Use this form to report rehospitalizations for REFRACTORY/SEVERE ISCHEMIA after the initial hospital discharge.
Did the patient have at least 5 minutes of chest pain or other clinical symptoms of ischemia?
5. Was patient on optimal medical therapy (2 anti-anginal agents)?
6. Were there ECG changes consistent with ischemia?
if ‘9’, specify:
8. Was thrombolytic therapy given to treat this event?
MEDICAL THERAPY DURING HOSPITALIZATION: No INTERVENTIONS DURING HOSPITALIZATION: If Yes, complete report: Complete CRF 15 Complete CRF 16 A&B Complete CRF 17 REFRACTORY ISCHEMIA:
Did the chest pain/ischemic symptoms lead to an intervention within 48 hours of symptom onset?
Fax this form to CCC Project Office within 48 hours of event
- REHOSPITALIZATION FOR UNSTABLE ANGINA-
MICHELANGELO: OTHER REHOSPITALIZATION REPORT REHOSPIT ALIZATION # DataFax #135 Plate #055 Croatia 191 Use this form to report rehospitalizations OTHER than those for MI, STROKE, REFRACTORY/SEVERE ISCHEMIA
4. Main reason for admission: (Mark [x] only one box)
Other cardiac arrhythmias (specify) Complete CRF 15 Complete CRF 16 A&B Complete CRF 17 Complete Bleeding Report CRF 75 Complete SAE Report CRF 70
Other reason for admission (specify)Fax this form to the CCC Project Office within 48 hours of event MICHELANGELO: SERIOUS ADVERSE EVENT REPORT SAE REPORT # DataFax #135 Plate #070 Croatia 191 COMPLETE ONE SERIOUS ADVERSE REPORT FOR EACH SERIOUS ADVERSE EVENT REPORTED. 1. Adverse Event Diagnosis 2. Date of Onset of Adverse Event (1st symptom) 3. Detailed Description of Adverse Event (if applicable) 4. Intensity 5. Relationship to Study Drug:
Is there a reasonable possibility that the AE was caused by the study drug?
6. Action taken: Was study drug stopped due to this event? 7. Corrective Therapies If Yes, specify: 8. Outcome of AE Complete Death Report CRF 99 9. Seriousness Criteria Date when event became serious
(if different from onset date recorded above)
( mark [X] all that apply)
Persistent or significant disability or incapacity
10. Study drug administered within 24 hours of onset of SAE 11. List relevant concomitant medications taken within 3 days of this SAE:
12 List recent and relevant medical history and concomitant diseases not reported on CRF 4: Fax SAE to CCC Project Office and Centre Monitor within 24 hours. MICHELANGELO: OASIS 5 SAE FOLLOW-UP REPORT SAE Follow-up Report # DataFax #135 Plate #071 Croatia 191 1. Date of Follow-up Evaluation: 2. Related SAE Report # Fax SAE Complementary Form to CCC Project Office and Centre Monitor within 24 hours. MICHELANGELO: OASIS 5 CLINICALLY SIGNIFICANT BLEEDING REPORT BLEEDING REPORT # DataFax #135 Plate #075 Croatia 191 Complete DEATH REPORT CRF 99 4. Details of Bleeding: (Mark [X] all that apply) (If Yes, complete Stroke Report CRF 40) 5. Was this bleeding event associated with any of the following? (Mark [X] all that apply)
6. Site/source: (mark [X] one box only)
Surgical bleeding (beyond that expected from the procedure)
7. Treatment of Bleeding other than blood Transfusion: (Mark [X] all that apply)
8. Were any of the following investigations performed? (Mark [X] all that apply)
9. Indicate whether any of the following medications were taken by the patient
a) < 24 hrs prior to bleeding event?
10. If considered serious bleeding, complete SAE Report CRF 70 Fax this form to the Project Office within 24 hours MICHELANGELO: OASIS 5 DEATH REPORT DataFax #135 Plate #099 Visit #099 Croatia 191
2. Cause of death:(mark [X] only one box) CARDIOVASCULAR a) Cardiac:
Other (specify): __________________
b) Other Vascular:
Other (specify): ____________________________________
c) Unknown Cause: NON-CARDIOVASCULAR: Record ONLY deaths due to documented non-vascular cause (e.g., malignancy, trauma, infection) here. (specify):______________________________________________________________
3. Final Follow-up Visit (CRFs 12 and 13) completed:
4. Study Completion CRF 14 completed: Fax this form to the Project Office within 48 hours of event
news from cardiology, neuroscience & trauma services at Borgess Winter 2014 CRASH–2 trial suggested that TXA was neither beneficial nor harmful in the treatment of traumatic intracranial hemorrhage and did not seem to increase the risk of stroke3. Because CRASH–2 was not designed to evaluate the efficacy of TXA usage in traumatic ICH, a large Traditionally, dictum regarding the man
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