drugset / Trial / NCT02897037

Bivalirudin in Acute Myocardial Infarction

NCT02897037

Phase 3 Unknown 380 enrolled Shenzhen Salubris Pharmaceuticals Co., Ltd.
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES. This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone. All enrolled patients would be followed-up to 30 days.

Timeline

Start
2016-11
Primary completion
2017-06
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bivalirudin Peptide 0.2 mg/kg Intravenous
Comparator Heparin Other / unclassified 100 iu/kg Intravenous