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

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laval University
• Treatments: Bivalirudin; Calcium heparin; Heparin; Hirudins

Criteria

Inclusion Criteria:

• At least two of the following additional criteria

• At least 70 yrs old

• Female gender

• Diabetes

• Creatinine clearance <60mL/min

• History of gastro-intestinal or other organ bleeding

• Baseline anemia

• Current treatment with glycoproteins IIb-IIIa inhibitors

Exclusion Criteria:

• Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for 12 months

• Concurrent participation in other investigational study

• Femoral sheath (artery)