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CompletedNCT00799045CANOAUpdated Feb 26, 2019

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

A Phase 4 interventional study of Clopidogrel in Migraine, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-26.

Sponsored by Laval University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Migraine

Keywords

  • Migraine
  • atrial septal defects
  • transcatheter
  • clopidogrel
03

In context

Migraine Disorders

1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.

This study's enrollment of 220 is above the median of 80 across 1,197 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Laval University is the lead sponsor of 380 studies on the registry; 70 are open to participants now.

Browse Laval University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
220 participants (actual)

Study arms

  • Experimental
    Aspirin + clopidogrel

    Aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months following ASD closure.

    Drug: Clopidogrel

  • Active comparator
    Aspirin

    Aspirin (80 mg/day) for 3 months following ASD closure.

    Drug: Clopidogrel

Interventions

  • DrugClopidogrel

    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.

    Also known as: Clopidogrel (Plavix)

06

What researchers measure

Primary outcomes

  1. Mean number of monthly migraine days per patient within the 3 months following transcatheter ASD closure.

    Time frame: 3 months

Secondary outcomes

  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

07

Study locations

1 site
  • Hopital Laval
    Québec, G1V 4G5, Canada
08

References and documents

Publications

  • Su TH, Wang JK, Kuo PH, Chang SH, Chiou LC, Lee WT, Fan PC. The pathogenic role of calcitonin gene-related peptide and predictors of new-onset migraine and long-term outcomes after transcatheter atrial septal defect closure. Headache. 2025 May;65(5):791-801. doi: 10.1111/head.14885. Epub 2024 Dec 11. PubMed 39660641 ↗
  • Wintzer-Wehekind J, Horlick E, Ibrahim R, Cheema AN, Labinaz M, Nadeem N, Osten M, Cote M, Marsal JR, Rivest D, Marrero A, Houde C, Rodes-Cabau J. Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: One-Year Results of the CANOA Randomized Clinical Trial. JAMA Cardiol. 2021 Feb 1;6(2):209-213. doi: 10.1001/jamacardio.2020.4297. PubMed 32965476 ↗
  • Rodes-Cabau J, Horlick E, Ibrahim R, Cheema AN, Labinaz M, Nadeem N, Osten M, Cote M, Marsal JR, Rivest D, Marrero A, Houde C. Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: The CANOA Randomized Clinical Trial. JAMA. 2015 Nov 24;314(20):2147-54. doi: 10.1001/jama.2015.13919. PubMed 26551304 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2008, a primary completion of Apr 2015 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2008
First posted
Nov 27, 2008
Start
Oct 2008
Primary completionActual
Apr 2015
CompletionActual
Dec 2016
Last update
Feb 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00799045
Lead sponsor
Laval University
Collaborators
Sanofi, Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Nov 27, 2008
Start date
Oct 2008
Primary completion
Apr 2015
Completion
Dec 2016
Last update
Feb 26, 2019

Study contacts

Josep Rodes-Cabau, MD
principal investigator · Hopital Laval

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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