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 个研究点目标入组 1,500 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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

发起方

Institute of Cardio Vascular Diseases