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

This study is currently recruiting participants.
Verified March 2017 by Olivier F. Bertrand, Laval University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01084993
First Posted: March 11, 2010
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Olivier F. Bertrand, Laval University
  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
Intervention Model: Parallel Assignment
Masking: None (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 Olivier F. Bertrand, Laval University:

Primary Outcome Measures:
  • Major bleeding and Mace [ Time Frame: 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:
  • EFFICACY and SAFETY PARAMETERS [ Time Frame: 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



Estimated Enrollment: 2000
Study Start Date: March 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Olivier F. Bertrand, MD, PhD, Laval University
ClinicalTrials.gov Identifier: NCT01084993     History of Changes
Other Study ID Numbers: EASY-B2B
First Submitted: March 9, 2010
First Posted: March 11, 2010
Last Update Posted: March 10, 2017
Last Verified: March 2017

Keywords provided by Olivier F. Bertrand, Laval University:
Coronary artery stenting, transradial, intracoronary

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