A clinical trial to study the effects of drug, Prasugrel in patients with acute coronary syndrome

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2009
INTERVENTION: Intervention1: Prasugrel: 10 mg daily Control Intervention1: Clopidrgrel: 75 mg daily CONDITION: Acute Coronary Syndrome PRIMARY OUTCOME: The primary efficacy end point will be a composite of the rate of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke during the follow‐up period. Additional prespecified analyses will include an analysis of the rates of the primary end point from randomization to day 3 and a landmark analysis of those data from day 3 to the end of the study.‐‐‐‐‐‐Timepoint: day 3 to end of study SECONDARY OUTCOME: Key secondary end points at 30 and 90 days will be the primary composite end point and a composite of death from cardiovascular causes, nonfatal myocardial infarction, or urgent target‐vessel revascularization  Additional secondary end points for the entire follow‐up period were stent thrombosis and a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or rehospitalization due to a cardiac ischemic event.‐‐‐‐‐‐Timepoint: 5 months INCLUSION CRITERIA: 1. All patients with duly filled in ICFs [Informed Consent Forms] 2. Ages: Eligible For Study: 18‐75Years, 3. Genders eligible for study: Both 4. The most important inclusion criteria for patients with unstable angina or non?ST‐elevation myocardial infarction are:  Ischemic symptoms lasting 10 minutes or more and occurring within 72 hours before randomization,  A TIMI risk score of 3 or more, and  Either ST‐segment deviation of 1 mm or more or  Elevated levels of a cardiac biomarker of necrosis. 5. Patients with ST‐elevation myocardial infarction could be enrolled within 12 hours after the onset of symptoms if primary PCI is planned or within 14 days after receiving medical treatment for ST‐elevation myocardial infarction.
Epistemonikos ID: 6d2d83b4a7ec92cc9719bb2a29c4403eae4f29fe
First added on: Aug 22, 2024