EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding (EASY-B2B)
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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 |
- 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)
- 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: | 100 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (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 |
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| 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 | |
| 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 | |
| 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 7, 2013 |
| 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 May 19, 2013