Study of Antiplatelet Therapy for Intracranial Aneurysm Stent-assisted Coiling

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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 by individualizing therapy.This trial is designed to demonstrate the superiority of a strategy of platelet function monitoring with dose adjustment in suboptimal responders as compared to a more conventional strategy without monitoring and without dose adjustment to reduce the primary end point evaluated 6 months after stent deployment in patients with intracranial aneurysms.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Treatments: Aspirin; Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria:

• 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 Criteria:

• •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