Health Condition 1: null- Acute Coronary Syndrome (ACS) patient population undergoing percutaneous coronary intervention
Conditions
Interventions
Intervention1: An observational registry - A Multicentric Prospective Observational Registry to evaluate safety, efficacy and cost effectiveness of using Bivalirudin in an Acute Coronary Syndrome (ACS
Sponsors
Institute of Cardio Vascular Diseases
Institute of Cardio Vascular Diseases
Eligibility
Inclusion 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
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 15 Dabigatran MUST be discontinued 1 to 2 days (CrCl >=50 mL/min) or 3 to 5 days (CrCl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To evaluate incidence of minor bleeding 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.) Safety endpoints-ARC defined Stent Thrombosis Timepoint: 30 days | — |
Countries
India
Contacts
Public ContactDr Ajit Mullasari MD
The Madras Medical Mission, Institute of Cardio Vascular Diseases
Outcome results
None listed