EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding
NCT ID: NCT01084993
Last Updated: 2018-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
2000 participants
INTERVENTIONAL
2010-03-31
2019-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bivalirudin
Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h
Bivalirudin
Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h
Heparin
70 U/kg or standard practice
Heparin
70 U/kg
Interventions
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Bivalirudin
Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h
Heparin
70 U/kg
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* Concurrent participation in other investigational study
* Femoral sheath (artery)
18 Years
ALL
No
Sponsors
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Laval University
OTHER
Responsible Party
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Olivier F. Bertrand
MD, PhD
Principal Investigators
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Olivier F Bertrand, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fondation IUCPQ
Locations
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Quebec Heart-Lung Institute
Québec, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EASY-B2B
Identifier Type: -
Identifier Source: org_study_id
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