None listed
Conditions
Interventions
Intervention1: Prasugrel: Loading Dose: 60mg, Maintenance dose: 10mg
Control Intervention1: Clopidogrel: Loading dose:300mg, Maintenance Dose: 75mg
Sponsors
TORRENT PHARMACEUTICALS LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 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
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 &#61607; History of hemorrhagic stroke &#61607; Intracranial neoplasm, arteriovenous malformation, or aneurysm &#61607; History of ischemic stroke/transient ischemic attack (TIA) &#61656; Platelet count of less than 100000/mm3 at the time of screening &#61656; Anaemia (haemoglobin < 10 g/dL) at the time of screening Prior/concomitant therapy exclusion criteria &#61656; One or more doses of a thienopyridine 5 days or less before PCI &#61656; Oral anticoagulation or other antiplatelet therapy that cannot be safely discontinued for the duration of the study other than aspirin &#61656; Daily treatment with nonsteroidal anti-inflammatory drugs or cyclooxygenase-2 inhibitors General exclusion criteria &#61656; Treatment within the last 30 days with an investigational drug or are presently enrolled in another drug or device study &#61656; Previously completed or withdrawn from this study or any other study investigating prasugrel &#61656; Women who are known to be pregnant, have given birth within the past 90 days, or are breast-feeding &#61656; Concomitant medical illness that in the opinion of the investigator is associated with reduced survival over the expected treatment period &#61656; Patients with liver enzymes more than 2.5X the upper limit normal and/or serum biluribin more than 1.5X the upper limit normal &#61656; Any condition associated with poor treatment compliance, including alcoholism, mental illness, or drug dependence &#61656; Intolerance of or allergy to aspirin, ticlopidine, or clopidogrel &#61656; Unable to adhere to protocol requirements and follow-up procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ? Inhibition of platelet aggregation (IPA) ? Nonfatal MI, or nonfatal stroke or rehospitalization due to a cardiac ischemic event. Timepoint: | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Death from cardiovascular causes, ? Urgent target-vessel revascularization Timepoint: | — |
Countries
India
Contacts
Public ContactDr. Ambrish Srivastava
Outcome results
None listed