Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm

NCT02675205 | Completed Phase 3

• 2 other identifiers: AGR_2014-332014-005720-10
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Aneurysm

Outcome Measures

Primary Outcomes (1)

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

  4 months

Study Arms (2)

clopidogrel-aspirin

ACTIVE COMPARATOR

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

Drug: Clopidogrel; Drug: aspirin

ticagrelor-aspirin

EXPERIMENTAL

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

Drug: Ticagrelor; Drug: aspirin

Interventions

Clopidogrel DRUG

clopidogrel: efficacy and safety in cerebral aneurysm stenting

clopidogrel-aspirin

Ticagrelor DRUG

ticagrelor:efficacy and safety in cerebral aneurysm stenting

ticagrelor-aspirin

aspirin DRUG

clopidogrel-aspirin; ticagrelor-aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Clopidogrel; Ticagrelor; Aspirin

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: February 5, 2016
• Study Start: December 1, 2015
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 16, 2021

Record last verified: 2021-07

Locations

FR (1)