Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm

Phase 3

Completed

• Conditions: Cerebral Aneurysm
• Interventions: Drug: Clopidogrel; Drug: Ticagrelor; Drug: aspirin

• Registration Number: NCT02675205
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

Part of interventional neuroradiology procedures for the treatment of selected cerebral aneurysms are now based on stenting. To reduce thromboembolic events, dual antiplatelet therapy (APT) combining aspirin and clopidogrel is proposed with close monitoring, since 1/3 of the patients are low responders due to variation of the biological response to clopidogrel . Ticagrelor is used by few teams but has never been evaluated in a randomized controlled trial. It could be an option for APT due to more reproducible response with less interindividual variability and reduced monitoring. The aim of this study is to demonstrate the interest of ticagrelor for the dual APT for platelet inhibition, in patients undergoing neurovascular stenting for cerebral aneurysm.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-30
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-05
• Primary Completion: 2020-07
• Study Completion: 2020-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• unruptured cerebral aneurysm
• elective endovascular treatment
• stenting required
• dual antiplatelet therapy required

Exclusion Criteria

-none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ticagrelor-aspirin	aspirin	Ticagrelor: 90 mg bid and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery
clopidogrel-aspirin	Clopidogrel	clopidogrel: 75mg and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery.
clopidogrel-aspirin	aspirin	clopidogrel: 75mg and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery.
ticagrelor-aspirin	Ticagrelor	Ticagrelor: 90 mg bid and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery

Primary Outcome Measures

Name	Time	Method
proportion of patients requiring at least one change of drug or dose adjustment to achieve platlet functional inhibition	4 months

Trial Locations

Locations (1)

Fondation Ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, France