A Multicentric (Max healthcare Hospital) Prospective Observational Investigator Initiated study to evaluate safety, efficacy and cost of effectiveness using Bivalirudin with provisional use of GP IIb/IIIa.
- Conditions
- Health Condition 1: null- Coronary heart Disease
- Registration Number
- CTRI/2012/12/003260
- Lead Sponsor
- Max Super Speciality hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 1000
Patients should be included if ALL of the following criteria are met:
•Age: 18 years or older
•Patient who can provide written informed consent for collection of data as approved by the ethics committee
•Patients undergoing PCI
Patients should be excluded if ANY of the following criteria is met:
•Patients who cannot provide informed consent for collection of data
•Allergy to bivalirudin or Aspirin, or known sensitivity to any component of the products
•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 PT15
•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
- Secondary Outcome Measures
Name Time Method