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

Primary Purpose

Cerebral Aneurysm

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Clopidogrel
Ticagrelor
aspirin
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-none

Sites / Locations

  • Fondation Ophtalmologique Adolphe de Rothschild

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

clopidogrel-aspirin

ticagrelor-aspirin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 30, 2015
Last Updated
July 15, 2021
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02675205
Brief Title
Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm
Acronym
TIC-TAC
Official Title
Ticagrelor Versus Clopidogrel for Platelet Inhibition in Patients Undergoing Neurovascular Stenting for Intracranial Aneurysm
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
clopidogrel-aspirin
Arm Type
Active Comparator
Arm Description
clopidogrel: 75mg and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery.
Arm Title
ticagrelor-aspirin
Arm Type
Experimental
Arm Description
Ticagrelor: 90 mg bid and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
clopidogrel: efficacy and safety in cerebral aneurysm stenting
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
ticagrelor:efficacy and safety in cerebral aneurysm stenting
Intervention Type
Drug
Intervention Name(s)
aspirin
Primary Outcome Measure Information:
Title
proportion of patients requiring at least one change of drug or dose adjustment to achieve platlet functional inhibition
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: unruptured cerebral aneurysm elective endovascular treatment stenting required dual antiplatelet therapy required Exclusion Criteria: -none
Facility Information:
Facility Name
Fondation Ophtalmologique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

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Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm

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