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

This study is currently recruiting participants.
Verified November 2013 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: November 11, 2013
Last verified: November 2013

March 9, 2010
November 11, 2013
March 2010
December 2013   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01084993 on ClinicalTrials.gov Archive Site
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

Same as current
Not Provided
Not Provided
 
EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Drug: Bivalirudin
    Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h
    Other Name: Angiomax
  • Drug: Heparin
    70 U/kg
    Other Name: Heparin
  • Active Comparator: Bivalirudin
    Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h
    Intervention: Drug: Bivalirudin
  • Active Comparator: Heparin
    70 U/kg or standard practice
    Intervention: Drug: Heparin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2014
December 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
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
Canada
 
NCT01084993
EASY-B2B
No
Olivier F. Bertrand, Laval University
Laval University
Not Provided
Principal Investigator: Olivier F Bertrand, MD, PhD IUCPQ
Laval University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP