DRUG
Bivalirudin
Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h
EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding
Status
Unknown
Phase
Phase 4
Enrollment
2,000
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
DRUG
Heparin
70 U/kg
Timeline
From registration to results.
First posted
Mar 11, 2010
Study start
Mar 2010
Primary completion
Sep 2018
Study completion
Jan 2019
Results posted
Not reported
Registry updated
Jan 31, 2018
Outcomes
What the study measures.
Primary outcomes
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 outcomes
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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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)
Study locations
1 registered sites.
Canada. Showing up to 24 locations stored in the fast local snapshot.
Quebec Heart-Lung Institute
Québec, Quebec, Canada
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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