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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Completed

CT.gov ID

NCT02675205

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Aneurysm	Drug: Clopidogrel Drug: Ticagrelor Drug: aspirin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Jul 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: clopidogrel-aspirin clopidogrel: 75mg and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery.	Drug: Clopidogrel clopidogrel: efficacy and safety in cerebral aneurysm stenting Drug: aspirin
Experimental: ticagrelor-aspirin Ticagrelor: 90 mg bid and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery	Drug: Ticagrelor ticagrelor:efficacy and safety in cerebral aneurysm stenting Drug: aspirin

Arm

Intervention/Treatment

Active Comparator: clopidogrel-aspirin

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

Drug: Clopidogrel

clopidogrel: efficacy and safety in cerebral aneurysm stenting

Drug: aspirin

Experimental: ticagrelor-aspirin

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

Drug: Ticagrelor

ticagrelor:efficacy and safety in cerebral aneurysm stenting

Drug: aspirin

Outcome Measures

Primary Outcome Measures

proportion of patients requiring at least one change of drug or dose adjustment to achieve platlet functional inhibition [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

-none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation Ophtalmologique Adolphe de Rothschild	Paris		France	75019

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT02675205

Other Study ID Numbers:

AGR_2014-33
2014-005720-10

First Posted:

Feb 5, 2016

Last Update Posted:

Jul 16, 2021

Last Verified:

Jul 1, 2021

Additional relevant MeSH terms:

Intracranial Aneurysm

Study Results

No Results Posted as of Jul 16, 2021