CTRI/2014/03/004452
Other
Phase 4
A Multicentric Prospective Observational Registry to evaluate safety, efficacy and cost effectiveness of using Bivalirudin in an Acute Coronary Syndrome (ACS) patient population undergoing percutaneous coronary intervention (PCI) in India.
Institute of Cardio Vascular Diseases0 sites1,500 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Acute Coronary Syndrome (ACS) patient population undergoing percutaneous coronary intervention
- Sponsor
- Institute of Cardio Vascular Diseases
- Enrollment
- 1500
- Status
- Other
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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