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

Last updated: January 29, 2018
Sponsor: Laval University
Overall Status: Trial Status Unknown

Phase

4

Condition

Chest Pain

Coronary Artery Disease

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT01084993
EASY-B2B
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

  • Concurrent participation in other investigational study

  • Femoral sheath (artery)

Study Design

Total Participants: 2000
Study Start date:
March 01, 2010
Estimated Completion Date:
January 31, 2019

Study 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.

Connect with a study center

  • Quebec Heart-Lung Institute

    Quebec, G1V 4G5
    Canada

    Active - Recruiting

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