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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Laval University
Sponsor:
Information provided by (Responsible Party):
Olivier F. Bertrand, Laval University
ClinicalTrials.gov Identifier:
NCT01084993
First received: March 9, 2010
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: Bivalirudin
Drug: Heparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding: Bivalirudin to Reduce Bleeding EASY-B2B Study

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Major bleeding and Mace [ Time Frame: 24h post-PCI and Discharge ] [ Designated as safety issue: No ]
    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:
  • EFFICACY and SAFETY PARAMETERS [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 2000
Study Start Date: March 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Angiomax
Active Comparator: Heparin
70 U/kg or standard practice
Drug: Heparin
70 U/kg
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084993

Contacts
Contact: Olivier F Bertrand, MD, PhD 418-656-8711 olivier.bertrand@criucpq.ulaval.ca
Contact: Michele Jadin, MSc 418-656-8711 ext 3007 michele.jadin@criucpq.ulaval.ca

Locations
Canada
Quebec Heart-Lung Institute Recruiting
Quebec, Canada, G1V 4G5
Contact: Michele Jadin, MSc    418-6568711 ext 3007    michele.jadin@crhl.ulaval.ca   
Principal Investigator: Olivier F Bertrand, MD, PhD         
Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: Olivier F Bertrand, MD, PhD IUCPQ
  More Information

No publications provided

Responsible Party: Olivier F. Bertrand, MD, PhD, Laval University
ClinicalTrials.gov Identifier: NCT01084993     History of Changes
Other Study ID Numbers: EASY-B2B
Study First Received: March 9, 2010
Last Updated: May 15, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Laval University:
Coronary artery stenting, transradial, intracoronary

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hemorrhage
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Calcium heparin
Bivalirudin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014