NCT02897037

Bivalirudin in Acute Myocardial Infarction

Bivalirudin vs Heparin During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Randomised Controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Bivalirudin	Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
DRUG	heparin	heparin monotherapy

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2016-09-12
• Last updated: 2016-11-28

Locations

1 site across 1 country: China