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Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm

NCT ID: NCT02675205

Last Updated: 2021-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cerebral Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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clopidogrel-aspirin

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

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

clopidogrel: efficacy and safety in cerebral aneurysm stenting

aspirin

Intervention Type DRUG

ticagrelor-aspirin

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

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

ticagrelor:efficacy and safety in cerebral aneurysm stenting

aspirin

Intervention Type DRUG

Interventions

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Clopidogrel

clopidogrel: efficacy and safety in cerebral aneurysm stenting

Intervention Type DRUG

Ticagrelor

ticagrelor:efficacy and safety in cerebral aneurysm stenting

Intervention Type DRUG

aspirin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

-none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2014-005720-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AGR_2014-33

Identifier Type: -

Identifier Source: org_study_id

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