Clinical trial NCT00799045: Clopidogrel For the Prevention of New Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Keywords: Migraine
atrial septal defects
transcatheter
clopidogrel
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Bristol-Myers Squibb
First posted: 2008-11-27
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean number of monthly migraine days per patient within the 3 months following transcatheter ASD closure.
timeFrame: 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.
timeFrame: 3 months
measure: Incidence of bleeding complications at 3-month follow-up.
timeFrame: 3 months
measure: Percentage of patients with new-onset migraine attacks.
timeFrame: 3 months
measure: Time to first migraine episode.
timeFrame: 3 months
measure: Percentage of patients with migraine headaches at 6-month and 1-year follow-up (exploratory only according to local feasibility).
timeFrame: 1 year
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Hopital Laval
Study officials:
affiliation: Hopital Laval
name: Josep Rodes-Cabau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wintzer-Wehekind J, Horlick E, Ibrahim R, Cheema AN, Labinaz M, Nadeem N, Osten M, Cote M, Marsal JR, Rivest D, Marrero A, Houde C, Rodes-Cabau J. Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: One-Year Results of the CANOA Randomized Clinical Trial. JAMA Cardiol. 2021 Feb 1;6(2):209-213. doi: 10.1001/jamacardio.2020.4297.
citation: Rodes-Cabau J, Horlick E, Ibrahim R, Cheema AN, Labinaz M, Nadeem N, Osten M, Cote M, Marsal JR, Rivest D, Marrero A, Houde C. Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: The CANOA Randomized Clinical Trial. JAMA. 2015 Nov 24;314(20):2147-54. doi: 10.1001/jama.2015.13919.