EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding (EASY-B2B)

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Bivalirudin; Drug: Heparin

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 Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Recruiting
    • Quebec Heart-Lung Institute
    • Contact: Michele Jadin, MSc; Phone Number: 3007 418-6568711; Email: michele.jadin@crhl.ulaval.ca
    • Principal Investigator: Olivier F Bertrand, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bivalirudin; Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h	Drug: Bivalirudin; Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h; Other Names: Angiomax
Active Comparator: Heparin; 70 U/kg or standard practice	Drug: Heparin; 70 U/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Laval University
• Investigators: Principal Investigator: Olivier F Bertrand, MD, PhD, Fondation IUCPQ

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: March 9, 2010
• First Submitted That Met QC Criteria: March 10, 2010
• First Posted (Estimate): March 11, 2010

Study Record Updates

• Last Update Posted (Actual): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Coronary artery stenting, transradial, intracoronary
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Heparin; Bivalirudin
• Other Study ID Numbers: EASY-B2B