CTRI/2009/091/000571
Completed
Phase 3
A prospective, randomised, double-blind, double dummy, comparative, parallel assignment, multicentric clinical trial to compare the safety and efficacy of Prasugrel vs. Clopidogrel in patients with moderate-to-high-risk Acute Coronary Syndromes who are to undergo Percutaneous Coronary Intervention (PCI).
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- TORRENT PHARMACEUTICALS LIMITED
- Enrollment
- 220
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria
- •\&\#61656;Patients with Acute coronary syndrome (UA/ NSTEMI or STEMI) who are to undergo PCI
- •\&\#61656;Males and Females \&\#8805;18 to \&\#8804;75 years
- •\&\#61656;Patients with body weight \&\#8805; 60 kg
- •\&\#61656;Patients willing to adhere to the protocol requirements
- •\&\#61656;Patients able to provide free, willing and written informed consent.
- •\&\#61656;For women of childbearing potential only, test negative for pregnancy between ACS presentation and enrolment (based on a urine pregnancy test) and agree to use a reliable method of birth control during the study
Exclusion Criteria
- •Exclusion Criteria
- •Cardiovascular exclusion criteria
- •\&\#61656;Cardiogenic shock at the time of randomization
- •\&\#61656;Refractory ventricular arrhythmias
- •\&\#61656;New York Heart Association class IV congestive heart failure
- •Bleeding risk exclusion criteria
- •\&\#61656;Active internal bleeding or history of bleeding diathesis
- •\&\#61656;Clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding
- •\&\#61656;Any of the following:
- •\&\#61607;History of diagnosed peptic ulcers/spontaneous GI bleeding
Outcomes
Primary Outcomes
Not specified
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