Clopidogrel For the Prevention of New Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects
Information source: Laval University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: Clopidogrel (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Laval University Official(s) and/or principal investigator(s):
Josep Rodes-Cabau, MD, Principal Investigator, Affiliation: Hopital Laval
Overall contact:
Josep Rodes-Cabau, MD, PhD, Phone: +1 418 656-8711, Email: josep.rodes@crhl.ulaval.ca
Summary
The addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset
migraine headache episodes following transcatheter ASD closure.
Clinical Details
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 design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Mean number of monthly migraine days per patient within the 3 months following transcatheter ASD closure.
Secondary outcome: 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.Incidence of bleeding complications at 3-month follow-up. Percentage of patients with new-onset migraine attacks. Time to first migraine episode. Percentage of patients with migraine headaches at 6-month and 1-year follow-up (exploratory only according to local feasibility).
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Josep Rodes-Cabau, MD, PhD, Phone: +1 418 656-8711, Email: josep.rodes@crhl.ulaval.ca
Hopital Laval, Quebec G1V 4G5, Canada; Recruiting
Josep Rodes-Cabau, MD, Phone: +1 418 656-8711, Email: josep.rodes@crhl.ulaval.ca
Melanie Cote, MSc, Phone: +1 418 656-8711, Email: Melanie.Cote@crhl.ulaval.ca
Josep Rodes-Cabau, MD, Principal Investigator
Additional Information
Starting date: October 2008
Ending date: October 2010
Last updated: November 26, 2008
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