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

Phase 3

• Conditions: Acute Coronary Syndrome

• Registration Number: CTRI/2009/091/000976
• Lead Sponsor: M/s. MSN Laboratories Ltd.

Brief Summary

This study is randomized,double blind,multicentr trial comparing the safety and efficacy of Tablet prasugrel with tablet Clopidogrel in the treatment of patients with acute coronary syndrome that will be conducted in four centres in India.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 200

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

• Patients unwilling to sign on ICF.Patients with known hypersensitivity to the study medicationsPatients with increased risk of bleeding, anemia, thrombocytopeniaPatients having complaints of hemoptysis, epistaxis or hemetemesisPatients with a history of pathologic intracranial findingsPatients 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 diseasePregnancy or breast-feeding Any other serious diseases having fatal progression.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	day 3 to end of study

Secondary Outcome Measures

Name	Time	Method
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.	5 months

Trial Locations

Locations (4)

Clinic ,Bhavnagar,Rajivoza59@hotmail.com; 🇮🇳 Bhavnagar, GUJARAT, India

Cooper Hospital, Vileparle(W), Mumbai, nitinmr64@yahoo.com; 🇮🇳 Mumbai, MAHARASHTRA, India

K.E.M.Hospital & Seth G.S. Medical College,Mumbai,pkirtic@yahoo.in; 🇮🇳 Mumbai, MAHARASHTRA, India

Smt. N H L Muni. Medical College,Ahmedabad,Rajpurvi@yahoo.com; 🇮🇳 Ahmadabad, GUJARAT, India

Clinic ,Bhavnagar,Rajivoza59@hotmail.com

🇮🇳Bhavnagar, GUJARAT, India

Dr. Rajiv R Oza

Principal investigator

Rajivoza59@hotmail.com