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

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ClinicalTrials.gov Identifier: NCT02675205
Recruitment Status : Recruiting
First Posted : February 5, 2016
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Tracking Information
First Submitted Date  ICMJE December 30, 2015
First Posted Date  ICMJE February 5, 2016
Last Update Posted Date June 23, 2020
Actual Study Start Date  ICMJE December 2015
Estimated Primary Completion Date June 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
proportion of patients requiring at least one change of drug or dose adjustment to achieve platlet functional inhibition [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Aneurysm
Intervention  ICMJE
  • Drug: Clopidogrel
    clopidogrel: efficacy and safety in cerebral aneurysm stenting
  • Drug: Ticagrelor
    ticagrelor:efficacy and safety in cerebral aneurysm stenting
  • Drug: aspirin
Study Arms  ICMJE
  • Active Comparator: clopidogrel-aspirin
    clopidogrel: 75mg and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery.
    Interventions:
    • Drug: Clopidogrel
    • Drug: aspirin
  • Experimental: ticagrelor-aspirin
    Ticagrelor: 90 mg bid and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery
    Interventions:
    • Drug: Ticagrelor
    • Drug: aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 2, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 16, 2021
Estimated Primary Completion Date June 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

-none

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laurence Salomon, M.D (33)1 48 03 6431 lsalomon@fo-rothschild.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02675205
Other Study ID Numbers  ICMJE AGR_2014-33
2014-005720-10 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor  ICMJE Fondation Ophtalmologique Adolphe de Rothschild
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fondation Ophtalmologique Adolphe de Rothschild
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP