BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial.
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.
Timeline
- Start
- 2012-08
- Primary completion
- 2013-07
- Completion
- 2014-07
Outcome
Met primary endpoint
paper Net adverse clinical events at 30 days occurred in 65 patients (8.8%) of 735 who were treated with bivalirudin compared with 96 patients (13.2%) PMID 25775052 ↗
paper treated with heparin (relative risk [RR], 0.67; 95% CI, 0.50-0.90; difference, -4.3%, 95% CI, -7.5% to -1.1%; P = .008) PMID 25775052 ↗
paper 124 patients (17.0%) of 730 treated with heparin plus tirofiban (RR for bivalirudin vs heparin plus tirofiban, 0.52; 95% CI, 0.39-0.69; difference, -8.1%, 95% CI, -11.6% to -4.7%; P < .001) PMID 25775052 ↗
Publications
- Liang Z, Li Y, Wang J, Wang D, Wang S, Ma L, Liu H, Yang L, Stone GW, Han Y. The safety and effectiveness of bivalirudin in female patients with acute myocardial infarction undergoing primary angioplasty: A subgroup analysis of the BRIGHT trial. Catheter Cardiovasc Interv. 2016 Mar;87 Suppl 1:608-15. doi: 10.1002/ccd.26407. Epub 2016 Jan 13.
- Han Y, Guo J, Zheng Y, Zang H, Su X, Wang Y, Chen S, Jiang T, Yang P, Chen J, Jiang D, Jing Q, Liang Z, Liu H, Zhao X, Li J, Li Y, Xu B, Stone GW; BRIGHT Investigators. Bivalirudin vs heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction: the BRIGHT randomized clinical trial. JAMA. 2015 Apr 7;313(13):1336-46. doi: 10.1001/jama.2015.2323.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bivalirudin | Peptide | 1.75 mg/kg | Intravenous |
| Comparator | Heparin | Other / unclassified | 60 iu/kg | Intravenous |
| Comparator | Heparin | Other / unclassified | 100 iu/kg | Intravenous |
| Comparator | Tirofiban | Other / unclassified | 0.15 ug/kg | Intravenous |