This study is conducted to collect real world data on effectiveness and safety of Bivalirudin, a blood thinner, in Indian patients undergoing angioplasty
- Conditions
- Health Condition 1: null- Acute Coronary Syndrome (ACS) patient population undergoing percutaneous coronary intervention
- Registration Number
- CTRI/2014/03/004452
- Lead Sponsor
- Institute of Cardio Vascular Diseases
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 1500
Patient who can provide Informed Consent Document signature form for collection of data as approved by the ethics committee
Acute Coronary Syndrome (ACS) patient undergoing percutaneous coronary intervention (PCI) in India
Patients who cannot provide Data Access Consent signature form for collection of data
Allergy to bivalirudin or Aspirin, or known sensitivity to any component of the products
Active major bleeding
Noncardiac coexisting conditions that could limit life expectancy to less than 1 year
Known pregnancy or nursing mothers. Women of child-bearing age will be screened for pregnancy and will have to adopt birth control measures till the duration of the study.
Treatment with Low Molecular Weight Heparin (LMWH) within 8 hours prior to the intervention
Warfarin MUST be discontinued prior to procedure, and the INR <=1.5, or the PT >15
Dabigatran MUST be discontinued 1 to 2 days (CrCl >=50 mL/min) or 3 to 5 days (CrCl <50 mL/min) prior to procedure
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate incidence of clinically significant major bleeding and combined adverse clinical events, defined as the combination of major bleeding or a composite of major adverse cardiovascular events (MACE), including death, reinfarction, target vessel revascularization for ischemia, and disabling strokeTimepoint: 30 days
- Secondary Outcome Measures
Name Time Method To evaluate incidence of minor bleeding <br/ ><br> <br/ ><br>â?¢Resource utilization, Sheath removal time, Length of Stay, Additional Lab Tests (ACTâ??s) and costs of managing complications (blood transfusion, additional ICU/CCU stay, Revascularization procedural cost etc.) <br/ ><br>Safety endpoints-ARC defined Stent Thrombosis <br/ ><br>Timepoint: 30 days