NCT01084993

EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding

EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding: Bivalirudin to Reduce Bleeding EASY-B2B Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Transradial coronary stenting is associated with less risk of access site complications and bleeding compared to femoral approach. Major bleeding post-PCI is a strong independent predictor of mortality and MACE. Depending of the antithrombotic regimen and access-site used, bleeding related to access-site represents 50-80% of the cases. Whereas transradial approach minimizes the risks of access-site bleeding, it has no impact on non-access site bleeding. Peri-procedural anemia is also an independent predictor of mortality and MACE. With femoral approach, bivalirudin compared to heparin ± glycoproteins IIb-IIIa has been associated with a significant reduction in access-site and non-access site related bleeding. In a post-hoc analysis of patients treated by transradial approach in ACUITY, there was a trend for non-access site bleeding (organ bleeding) with bivalirudin compared to heparin ± glycoproteins IIb-IIIa. HYPOTHESES: In patients at high-risk of peri-procedural bleeding, bivalirudin ± glycoproteins IIb-IIIa reduces the risk of bleeding compared to heparin ± glycoproteins IIb-IIIa. In patients at high-risk of bleeding and undergoing transradial PCI, bivalirudin significantly reduces the incidence of non-access site bleeding and peri-procedural anemia.

Detailed description

OBJECTIVES: The primary objective is to compare the incidence of major bleeding and anemia 24h post-PCI in patients at high-risk of bleeding after transradial PCI with heparin or bivalirudin.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Bivalirudin	Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h
DRUG	Heparin	70 U/kg

Timeline

• Start date: 2010-03-01
• Primary completion: 2018-09-01
• Completion: 2019-01-01
• First posted: 2010-03-11
• Last updated: 2018-01-31

Locations

1 site across 1 country: Canada