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

Coronary Artery Disease Clinical Trial

— EASY-B2B  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01084993
• Other study ID #: EASY-B2B
• Status: Recruiting
• Phase: Phase 4
• First received: March 9, 2010
• Last updated: January 29, 2018
• Start date: March 2010
• Est. completion date: January 2019

Study information

• Verified date: January 2018
• Source: Laval University
• Contact: Olivier F Bertrand, MD, PhD
• Phone: 418-656-8711
• Email: olivier.bertrand[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Bivalirudin
Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h
• Heparin
70 U/kg

Locations

Country	Name	City	State
Canada	Quebec Heart-Lung Institute	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major bleeding and Mace	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)	24h post-PCI and Discharge
Secondary	EFFICACY and SAFETY PARAMETERS	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	30 days