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

February 25, 2019 updated by: Laval University

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Hôpital Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Clopidogrel (Plavix)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean number of monthly migraine days per patient within the 3 months following transcatheter ASD closure.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months
Incidence of bleeding complications at 3-month follow-up.
Time Frame: 3 months
3 months
Percentage of patients with new-onset migraine attacks.
Time Frame: 3 months
3 months
Time to first migraine episode.
Time Frame: 3 months
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Bristol-Myers Squibb
Sanofi

Investigators

  • Principal Investigator: Josep Rodes-Cabau, MD, Hôpital Laval

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

November 26, 2008

First Submitted That Met QC Criteria

November 26, 2008

First Posted (ESTIMATE)

November 27, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLOPI_L_03563

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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