Clopidogrel For the Prevention of New Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects - Full Text View

Sponsor:	Laval University
Collaborators:	Sanofi-Aventis Bristol-Myers Squibb
Information provided by:	Laval University
ClinicalTrials.gov Identifier:	NCT00799045

Purpose

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

Condition	Intervention	Phase
Migraine	Drug: Clopidogrel	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:

Mean number of monthly migraine days per patient within the 3 months following transcatheter ASD closure. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Incidence of bleeding complications at 3-month follow-up. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Percentage of patients with new-onset migraine attacks. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Time to first migraine episode. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Percentage of patients with migraine headaches at 6-month and 1-year follow-up (exploratory only according to local feasibility). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Aspirin + clopidogrel: Experimental Aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months following ASD closure.	Drug: Clopidogrel 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.
Aspirin: Active Comparator Aspirin (80 mg/day) for 3 months following ASD closure.	Drug: Clopidogrel 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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799045

Contacts

Contact: Josep Rodes-Cabau, MD, PhD

+1 418 656-8711

josep.rodes@crhl.ulaval.ca

Locations

Canada
Hopital Laval	Recruiting
Quebec, Canada, G1V 4G5
Contact: Josep Rodes-Cabau, MD +1 418 656-8711 josep.rodes@crhl.ulaval.ca
Contact: Melanie Cote, MSc +1 418 656-8711 Melanie.Cote@crhl.ulaval.ca
Principal Investigator: Josep Rodes-Cabau, MD

Sponsors and Collaborators

Laval University

Sanofi-Aventis

Bristol-Myers Squibb

Investigators

Principal Investigator:

Josep Rodes-Cabau, MD

Hopital Laval

More Information

No publications provided

Responsible Party:	Hopital Laval ( Josep Rodes-Cabau, MD )
Study ID Numbers:	CLOPI_L_03563
Study First Received:	November 26, 2008
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00799045 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Laval University:

Migraine
atrial septal defects
transcatheter
clopidogrel
New-onset migraine headache episodes following transcatheter atrial septal defects closure

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Pain
Headache Disorders, Primary
Fibrinolytic Agents
Brain Diseases
Heart Septal Defects, Atrial
Headache Disorders
Signs and Symptoms
Fibrin Modulating Agents
Migraine Disorders
Therapeutic Uses
Headache
Cardiovascular Diseases

Congenital Abnormalities
Heart Septal Defects
Heart Diseases
Ticlopidine
Cardiovascular Abnormalities
Nervous System Diseases
Central Nervous System Diseases
Cardiovascular Agents
Pharmacologic Actions
Clopidogrel
Neurologic Manifestations
Platelet Aggregation Inhibitors
Heart Defects, Congenital

ClinicalTrials.gov processed this record on February 08, 2010