Status:
UNKNOWN
Study of Antiplatelet Therapy for Intracranial Aneurysm Stent-assisted Coiling
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Embolic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Patients' responses to oral antiplatelet therapy are subject to variation. Bedside monitoring offers the opportunity to improve outcomes of intracranial aneurysm patients undergoing stent deployment b...
Detailed Description
Participating Centers : 10 China high neurointervention volume (\>200) centers Rationale: Clopidogrel (75 mg/day), in combination with aspirin (100 mg/day), is currently the antiplatelet treatment of ...
Eligibility Criteria
Inclusion
- Patients (≥18 years) in whom elective intracranial stent placement is scheduled after diagnostic angiography
- Patients not treated by GPIIb/IIIa inhibitors prior to randomization.
- Provided written consent for participation in the trial prior to any study-specific procedures or requirements
Exclusion
- •Oral anticoagulation (Vitamin K Antagonists).
- Contraindication for aspirin and/or clopidogrel or GPIIb/IIIa inhibitors or to increasing dose of clopidogrel or aspirin
- Ongoing or recent bleeding and/or recent major surgery (\<3 weeks)
- Severe liver dysfunction
- Thrombocytopenia (Platelet count \<80000/µl).
- IIb/IIIa inhibitors within a week prior to randomization
- multiple intracranial aneurysms
- Patient at risk of poor compliance to the study
- Patient not affiliated to social security
- Pregnant women, no signed inform consent
- Any invasive or surgical planned intervention during the year after stent placement
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
1856 Patients enrolled
Trial Details
Trial ID
NCT02224131
Start Date
January 1 2015
End Date
December 1 2020
Last Update
August 25 2014
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100050