Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm (TIC-TAC)

Fondation Ophtalmologique Adolphe de Rothschild

Status and phase: Completed; Phase 3

Conditions: Cerebral Aneurysm

Treatments: Drug: Ticagrelor; Drug: aspirin; Drug: Clopidogrel

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02675205

2014-005720-10 (EudraCT Number)

AGR_2014-33

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

-none

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

clopidogrel-aspirin

Active Comparator group

Description:

clopidogrel: 75mg and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery.

Treatment:

Drug: Clopidogrel

Drug: aspirin

ticagrelor-aspirin

Experimental group

Description:

Ticagrelor: 90 mg bid and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery

Treatment:

Drug: aspirin

Drug: Ticagrelor