Status:
COMPLETED
Angioplasty to Blunt the Rise of Troponin in Acute Coronary Syndrome (ACS)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Release of troponin evaluated by the peak of troponin during the hospital phase.Because of its sensitivity and specificity as well as its widespread use in routine practice, rise in troponin levels is...
Detailed Description
We propose to evaluate the optimal moment for catheterization in patients presenting with acute coronary syndromes by comparing rapid catheterization on the day of admission (within 8 hours of admissi...
Eligibility Criteria
Inclusion
- Man over 18 or non-pregnant woman over 18.
- Patient hospitalized for severe acute coronary syndrome. To be selected patients will need to have at least 2 criteria for acute coronary syndrome AND a TIMI score \> 3 for severity of ACS.
- ACS is defined by at least two of the following diagnostic criteria :
- ischemic symptom
- electrocardiographic abnormalities in the ST segment (depression or transitory elevation of at least 0.1 mV), or in the T waves, at least in two contiguous leads positive troponin (as defined locally).
- Severity of ACS is defined by a TIMI score \> 3
- indication for catheterization agreed and possible within the following 8 hours.
- signed consent form
Exclusion
- Patients that would require immediate catheterization for ongoing refractory ischemia, major arrhythmias, or hemodynamic instability are not eligible for the study.
- Anticoagulant therapy with antivitamin K within 5 days preceding randomization
- Thrombolytic therapy during the preceding 24 hours
- Upstream treatment by a GPIIb/IIIa inhibitor
- ReoPro should not be administered to patients with known sensitivity to abciximab, to any component of the product or to murine monoclonal antibodies. Because inhibition of platelet aggregation increases the risk of bleeding, ReoPro is contra-indicated in the following clinical situations: active internal bleeding; history of cerebrovascular accident within two years; recent (within two months) intracranial or intraspinal surgery or trauma; recent (within two months) major surgery; intracranial neoplasm, arteriovenous malformation or aneurysm; known bleeding diathesis or severe uncontrolled hypertension; pre-existing thrombocytopenia; vasculitis; hypertensive or diabetic retinopathy; severe hepatic or severe renal failure.
- Woman nursing
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00442949
Start Date
August 1 2006
End Date
January 1 2009
Last Update
February 12 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut de Cardiologie - Hôpital Pitié-Salpétrière
Paris, France, 75013