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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Drug: Bivalirudin; Drug: Heparin

• Registration Number: NCT01084993
• Lead Sponsor: Laval University

Brief 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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-10
• Study First Posted: 2010-03-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-31
• Primary Completion: 2018-09
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bivalirudin	Bivalirudin	Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h
Heparin	Heparin	70 U/kg or standard practice

Primary Outcome Measures

Name	Time	Method
Major bleeding and Mace	24h post-PCI and Discharge	The primary end-points will be 1) the incidence of major bleeding (Replace-2 criteria) at hospital discharge and 2) the incidence of 24h post-PCI anemia (WHO criteria)

Secondary Outcome Measures

Name	Time	Method
EFFICACY and SAFETY PARAMETERS	30 days	The composite of death, MI (def 1 : Tn-t \> 0.1 and def 2 : CK-MB \> 30μg/l), urgent revascularization and major bleeding at 30 days post-PCI.; The incidence of ARC-defined stent thrombosis at 30 days. The incidence of access-site hematoma according to EASY scale. The incidence of radial artery occlusion at hospital discharge according to echo-doppler evaluation

Trial Locations

Locations (1)

Quebec Heart-Lung Institute; 🇨🇦 Quebec, Canada