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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Laval University.
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborators:
Sanofi
Bristol-Myers Squibb
Information provided by (Responsible Party):
Laval University
ClinicalTrials.gov Identifier:
NCT00799045
First received: November 26, 2008
Last updated: May 11, 2015
Last verified: May 2015
  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 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


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 ]

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 ]
  • 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 ]

Estimated Enrollment: 150
Study Start Date: October 2008
Estimated Study Completion Date: April 2016
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada
Hopital Laval
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Sanofi
Bristol-Myers Squibb
Investigators
Principal Investigator: Josep Rodes-Cabau, MD Hopital Laval
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT00799045     History of Changes
Other Study ID Numbers: CLOPI_L_03563
Study First Received: November 26, 2008
Last Updated: May 11, 2015

Keywords provided by Laval University:
Migraine
atrial septal defects
transcatheter
clopidogrel

Additional relevant MeSH terms:
Migraine Disorders
Headache
Heart Septal Defects
Heart Septal Defects, Atrial
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on September 21, 2017