A clinical trial to study the effects of two drugs, prasugrel and clopidogrel in patients with acute coronary syndrome who are to undergo percutaneous interventio
- Registration Number
- CTRI/2009/091/000571
- Lead Sponsor
- TORRENT PHARMACEUTICALS LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 220
Inclusion Criteria
Patients with Acute coronary syndrome (UA/ NSTEMI or STEMI) who are to undergo PCI
Males and Females ≥18 to ≤75 years
Patients with body weight ≥ 60 kg
Patients willing to adhere to the protocol requirements
Patients able to provide free, willing and written informed consent.
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
Cardiovascular exclusion criteria
Cardiogenic shock at the time of randomization
Refractory ventricular arrhythmias
New York Heart Association class IV congestive heart failure
Bleeding risk exclusion criteria
Active internal bleeding or history of bleeding diathesis
Clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding
Any of the following:
History of diagnosed peptic ulcers/spontaneous GI bleeding
History of hemorrhagic stroke
Intracranial neoplasm, arteriovenous malformation, or aneurysm
History of ischemic stroke/transient ischemic attack (TIA)
Platelet count of less than 100000/mm3 at the time of screening
Anaemia (haemoglobin < 10 g/dL) at the time of screening
Prior/concomitant therapy exclusion criteria
One or more doses of a thienopyridine 5 days or less before PCI
Oral anticoagulation or other antiplatelet therapy that cannot be safely discontinued for the duration of the study other than aspirin
Daily treatment with nonsteroidal anti-inflammatory drugs or cyclooxygenase-2 inhibitors
General exclusion criteria
Treatment within the last 30 days with an investigational drug or are presently enrolled in another drug or device study
Previously completed or withdrawn from this study or any other study investigating prasugrel
Women who are known to be pregnant, have given birth within the past 90 days, or are breast-feeding
Concomitant medical illness that in the opinion of the investigator is associated with reduced survival over the expected treatment period
Patients with liver enzymes more than 2.5X the upper limit normal and/or serum biluribin more than 1.5X the upper limit normal
Any condition associated with poor treatment compliance, including alcoholism, mental illness, or drug dependence
Intolerance of or allergy to aspirin, ticlopidine, or clopidogrel
Unable to adhere to protocol requirements and follow-up procedures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method