Health Condition 1: null- Acute coronary syndrome undergoing percutaneous coronary intervention
Conditions
Interventions
Intervention1: Prasugrel: loading dose-60mg
maintenance dose-10mg once daily for total of 90 days
Control Intervention1: Clopidogrel: loading dose-300mg
maintenance dose-75 mg once daily for total of 90 days
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Patients meeting all below mentioned criteria (1) Male or female patients in the age group of 18to74 years. (2) Diagnosed cases of Acute coronary syndrome (ACS) patients (with TIMI RISK Score greater or equal to 3) selected for elective PCI. (3) Patients willing to give informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Patients meeting any of the following criteria: (1) Cardiovascular exclusion criteria: - Patients with cardiogenic shock at the time of randomization. - Patients with severe heart failure (class III & IV according to Killip classification). - Patients with refractory ventricular arrhythmias. (2) Bleeding & related risk exclusion criteria: - Patients who have received fibrin specific fibrinolytic therapy less than 24 hours before randomization. - Patients who have received non-fibrin specific fibrinolytic therapy less than 48 hours before randomization. - Patients with active internal bleeding. - Patients with propensity to bleed (e.g. due to recent trauma, recent surgery, recent or recurrent gastrointestinal bleeding or active peptic ulcer disease, or patients with known intracranial neoplasm, arteriovenous malformation , aneurysm, international normalized ration (INR) > 1.5, platelet count < 100,000/mm3). - Patients with history of hemorrhagic cerebrovascular accident. - Patients with ischemic stroke within 03 months prior to screening. - Patients with anaemia (Hb less than 10 gm/dl) at the time of screening. - Clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding. (3) Concomitant or prior drug therapy exclusion criteria - Patients receiving or who are likely to receive oral anti-coagulation therapy that cannot be safely discontinued for the duration of the trial. - Patients receiving daily treatment of NSAIDs or cyclooxygenase-2 inhibitors that can not be discontinued. (4) General exclusion criteria - Patients with intolerance of or allergy to thienopyridine. - Patients who has a severe liver disease, such as cirrhosis. - Patients with elevated serum creatinine more than 1.5 times ULN. - Females who are known to be pregnant, have given birth within the past 90 days, or are breastfeeding or unwilling to practice birth control measures during the study duration. - Concomitant medical illness that in the opinion of the investigator is associated with reduced survival over the expected treatment period. - Any condition associated with poor treatment compliance, including alcoholism, mental illness or drug dependence. - Patients with body weight < 60 kg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy end point : Composite end point of :  Death due to myocardial infarction or stroke  non-fatal myocardial infarction or non-fatal stroke Timepoint: From randomization till the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy end points :  Individual elements of composite end point  Incidence of stent thrombosis  Need for urgent target vessel revascularization. Safety end point:  Incidence of TIMI-major bleeding  Incidence of TIMI-minor bleedingTimepoint: From randomization till the end of treatment | — |
Countries
India
Contacts
Public ContactDr Dimple Shah
Intas Pharma
Outcome results
None listed