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Clopidogrel For the Prevention of New Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects (CANOA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00799045
Recruitment Status : Completed
First Posted : November 27, 2008
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
Sanofi
Bristol-Myers Squibb
Information provided by (Responsible Party):
Laval University

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

Condition or disease Intervention/treatment Phase
Migraine Drug: Clopidogrel Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : October 2008
Actual Primary Completion Date : April 2015
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Aspirin + clopidogrel
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.
Other Name: Clopidogrel (Plavix)
Active Comparator: Aspirin
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.
Other Name: Clopidogrel (Plavix)


Outcome Measures
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Primary Outcome Measures :
  1. Mean number of monthly migraine days per patient within the 3 months following transcatheter ASD closure. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Incidence of bleeding complications at 3-month follow-up. [ Time Frame: 3 months ]
  3. Percentage of patients with new-onset migraine attacks. [ Time Frame: 3 months ]
  4. Time to first migraine episode. [ Time Frame: 3 months ]
  5. 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799045


Locations
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Canada
Hopital Laval
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Sanofi
Bristol-Myers Squibb
Investigators
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Principal Investigator: Josep Rodes-Cabau, MD Hopital Laval
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT00799045    
Other Study ID Numbers: CLOPI_L_03563
First Posted: November 27, 2008    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Keywords provided by Laval University:
Migraine
atrial septal defects
transcatheter
clopidogrel
Additional relevant MeSH terms:
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Migraine Disorders
Heart Septal Defects
Heart Septal Defects, Atrial
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs