NCT01696110

BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial.

Bivalirudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin Undergoing Angioplasty (BRIGHT):a Randomised Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,194 (actual)
• Sponsor: Shenyang Northern Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study would enrolled a total of 2100 AMI patients undergoing PCI to one of three antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor. All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.

Detailed description

This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 2100 AMI patients undergoing percutaneous coronary intervention (PCI) to one of three antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor. All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.

Conditions

• Acute Myocardial Infarction
• Percutaneous Coronary Intervention

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
DRUG	heparin plus tirofiban	combined use of heparin and tirofiban during PCI

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-07-01
• Completion: 2014-07-01
• First posted: 2012-09-28
• Last updated: 2014-10-01

Locations

81 sites across 1 country: China