Overview

This trial is active, not recruiting.

Condition migraine
Treatment clopidogrel
Phase phase 4
Sponsor Laval University
Collaborator Sanofi
Start date October 2008
End date April 2015
Trial size 150 participants
Trial identifier NCT00799045, CLOPI_L_03563

Summary

The addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset migraine headache episodes following transcatheter ASD closure.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months following ASD closure.
clopidogrel Clopidogrel (Plavix)
Patients will be randomized either to aspirin (80 mg/day) or aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months following ASD closure.
(Active Comparator)
Aspirin (80 mg/day) for 3 months following ASD closure.
clopidogrel Clopidogrel (Plavix)
Patients will be randomized either to aspirin (80 mg/day) or aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months following ASD closure.

Primary Outcomes

Measure
Mean number of monthly migraine days per patient within the 3 months following transcatheter ASD closure.
time frame: 3 months

Secondary Outcomes

Measure
Severity of migraine attacks following ASD closure as evaluated by the intensity of migraine episodes and the Migraine Disability Assessment (MIDAS) questionnaire at 3-month follow-up after ASD closure.
time frame: 3 months
Incidence of bleeding complications at 3-month follow-up.
time frame: 3 months
Percentage of patients with new-onset migraine attacks.
time frame: 3 months
Time to first migraine episode.
time frame: 3 months
Percentage of patients with migraine headaches at 6-month and 1-year follow-up (exploratory only according to local feasibility).
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients ≥ 18 year old undergoing transcatheter ASD closure with the Amplatzer Septal Occluder device (AGA medical Corp., MN, USA). - Female subjects must be post-menopausal, surgically sterile, or using an effective method of birth control. - Signed an informed consent document. Exclusion Criteria: - Allergy or intolerance to any of the antithrombotic drugs (aspirin, clopidogrel) used in the study. - Need for anticoagulation therapy. - Use of ASD closure devices other than the Amplatzer Septal Occluder device. - History of migraine headaches (based on migraine headache questionnaire). - Refusal to sign the informed consent. - Pregnancy or breast-feeding or planning to become pregnant during the study. - Previous stroke.

Additional Information

Official title Clopidogrel On Top of Aspirin For the Prevention of New Onset Migraine Headache Occurrence Following Transcatheter Closure of Atrial Septal Defects: A Prospective Randomized Trial (the CANOA Study)
Principal investigator Josep Rodes-Cabau, MD
Description The objective is to evaluate the incidence and severity of new-onset migraine headache episodes following transcatheter ASD closure in patients treated with aspirin alone compared to those on aspirin + clopidogrel therapy as antithrombotic treatment after the procedure. This is a prospective, randomized, double blind, multicenter study, including patients with no previous history of migraine attacks who have been diagnosed with an ASD and for whom transcatheter ASD closure has been clinically indicated. Patients will be randomized either to aspirin (80 mg/day) or aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months following ASD closure. The occurrence and severity of migraine headaches will be evaluated by a neurologist using a structured headache questionnaire at 1 month and 3 months following ASD closure. An additional 6 month and 1 year follow-up evaluation will be exploratory according to local feasibility.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Laval University.