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

Phase 3

Completed

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• 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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified