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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00220571 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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CARESS in Acute Myocardial Infarction
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Scientific title:
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Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction |
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Date of first enrolment:
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May 2003 |
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Target sample size:
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600 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00220571 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Italy
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Poland
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Contacts
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Name:
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Gabriel P. Steg, MD. Ph D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hopital Bichat - Paris France |
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Name:
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Darius Dudek, MD, Ph D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Jagellonian University Krakow Poland |
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Name:
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Leonardo Bolognese, MD, Ph D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ospedale San Donato - Arezzo Italy |
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Name:
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Carlo Di Mario, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Royal Brompton and Harefield Hospital - London UK |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ECG with ST-elevation (= 1mm in at least 2 ECG limb leads or = 2 mm in 2 contiguous
precordial leads) AMI within <12 hours from symptoms onset fulfilling 1 or more of the
following criteria of “high risk”:
1. Summation of ST-segment elevation or depression = 15 mm in all 12
electrocardiographic leads or new onset complete left bundle branch block;
2. Previous myocardial infarction (Q- and non Q-wave);
3. Killip Class 2 or 3;
4. LV ejection fraction at transthoracic ultrasound < 40%.
Exclusion Criteria:
1. Inability to provide informed consent;
2. Age > 75 years
3. CABG or PCI procedure in past history involving the infarct-related artery;
4. Participation in another study with any investigational drug or device within the
previous 30 days;
5. Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer);
6. Cardiogenic shock (hypotension with Systolic Blood Pressure (SBP) < 90 mmHg and
tachycardia > 100 beats / min, not due to hypovolemia and requiring inotropic support
or balloon counterpulsation);
7. Need for concomitant major surgery (e.g. valve surgery or resection of aortic or left
ventricular aneurysm, carotid endarterectomy, abdominal aortic aneurysm surgery,
congenital heart disease etc);
8. Severe hepatic disease;
9. Patients with acute or chronic renal impairment (serum creatinine > 2.0 mg % or 200
mg/l or creatinine clearance < 30 ml/min);
10. Transmural MI in different location within the previous week;
11. Previous administration of thrombolytics within 7 days;
12. Intolerance or contraindications to ASA or Clopidogrel;
13. Known leucopenia, defined as a leukocyte count of < 3.500 White Blood Cells (WBC)/ml
14. Known neutropenia, defined as < 1000 neutrophils / ml;
15. Known thrombocytopenia (< 100.000 platelets / ml );
16. Documented active peptic ulcer or upper gastrointestinal bleeding within the previous
6 months;
17. Previous hemorrhagic stroke;
18. Previous ischemic cerebrovascular event within 3 months;
19. Intracranial neoplasm;
20. Recent major surgery at risk of bleeding;
21. Episodes of uncontrolled hypertension (> 180/110 mmHg despite treatment) in past 2
years;
22. Administration of oral anticoagulants within the previous 7 days unless INR = 1.2;
23. Severe recent trauma;
24. Known or possible pregnancy;
25. Absence of suitable vascular access (diffuse peripheral arterial disease);
26. Basal ECG changes which make identification of ST-segment elevation impossible (i.e.:
ventricular activation from artificial pacemaker, etc.).
Age minimum:
N/A
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myocardial Infarction
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Intervention(s)
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Device: Coronary Angioplasty (PTCA)
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Primary Outcome(s)
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To compare 30 days incidence of the composite end-point of: mortality, reinfarction and refractory ischemia in the two arms of the study.
[Time Frame: 30 Day]
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Secondary Outcome(s)
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Compare 1 year composite end-point of: mortality, reinfarction, refractory ischemia, hospital readmission because of heart failure in the two arms;
[Time Frame: 1 Year]
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Compare the incidence of in-hospital stroke and bleeding complications in the two arms.
[Time Frame: 30 Day]
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Compare the resource use at 30 days and 1 year, including days in CCU, MICU or general ward, cost of catheterization and PTCA, drugs, ambulance service during index hospitalization and subsequent hospital admissions for reAMI
[Time Frame: 30 Day and 1 Year]
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Secondary ID(s)
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2003OE001B
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IIT(IT) H4S-IT-O038
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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