Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm

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Brief Title

Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm

Official Title

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

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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


Condition

Cerebral Aneurysm

Intervention

Clopidogrel

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

December 2015

Completion Date

September 16, 2021

Primary Completion Date

June 16, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  unruptured cerebral aneurysm

          -  elective endovascular treatment

          -  stenting required

          -  dual antiplatelet therapy required

        Exclusion Criteria:

        -none
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, (33)1 48 03 6431, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02675205

Organization ID

AGR_2014-33

Secondary IDs

2014-005720-10

Responsible Party

Sponsor

Study Sponsor

Fondation Ophtalmologique Adolphe de Rothschild


Study Sponsor

, , 


Verification Date

June 2020