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NCT02675205 Clinical Trial

Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm

Cerebral Aneurysm Clinical Trial

— TIC-TAC  

Official title:
Ticagrelor Versus Clopidogrel for Platelet Inhibition in Patients Undergoing Neurovascular Stenting for Intracranial Aneurysm

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02675205
Other study ID # AGR_2014-33
Secondary ID 2014-005720-10
Status Completed
Phase Phase 3
First received
Last updated
Start date December 2015
Est. completion date December 2020

Study information
Verified date July 2021
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2020
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - unruptured cerebral aneurysm - elective endovascular treatment - stenting required - dual antiplatelet therapy required Exclusion Criteria: -none

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Clopidogrel
clopidogrel: efficacy and safety in cerebral aneurysm stenting
• Ticagrelor
ticagrelor:efficacy and safety in cerebral aneurysm stenting
• aspirin

Locations
Country Name City State
France Fondation Ophtalmologique Adolphe de Rothschild Paris

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary proportion of patients requiring at least one change of drug or dose adjustment to achieve platlet functional inhibition 4 months
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