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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 : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

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



Primary Outcome Measures :
  1. proportion of patients requiring at least one change of drug or dose adjustment to achieve platlet functional inhibition [ Time Frame: 4 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675205


Contacts
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Contact: Laurence Salomon, M.D (33)1 48 03 6431 lsalomon@fo-rothschild.fr

Locations
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France
Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: ANNE GODIER, MD, PhD       agodier@fo-rothschild.fr   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02675205     History of Changes
Other Study ID Numbers: AGR_2014-33
2014-005720-10 ( EudraCT Number )
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Brain Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Aspirin
Clopidogrel
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists