None listed
Conditions
Interventions
Intervention1: Prasugrel: 10 mg daily
Control Intervention1: Clopidrgrel: 75 mg daily
Sponsors
M/s. MSN Laboratories Ltd.
Eligibility
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: Patients unwilling to sign on ICF. Patients with known hypersensitivity to the study medications Patients with increased risk of bleeding, anemia, thrombocytopenia Patients having complaints of hemoptysis, epistaxis or hemetemesis Patients with a history of pathologic intracranial findings Patients with the use of any thienopyridine within 5 days before enrollment. Patients with significant renal impairment (Blood Urea Nitrogen, >35 mg/dL; Serum Creatinine, >2.5 mg/dL; Or Creatinine Clearance, <40 ml/min Per 1.73 m2 of body surface area), Patients with severe hepatic disease Pregnancy or breast-feeding Any other serious diseases having fatal progression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 &#61607; 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 | — |
Countries
India
Contacts
Public ContactDr. Nitin M Rathod
Outcome results
None listed