NCT00799045

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2008

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

6.5 years

First QC Date

November 26, 2008

Last Update Submit

February 25, 2019

Conditions

Migraine

Keywords

Migraineatrial septal defectstranscatheterclopidogrel

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (5)

  • 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.

    3 months

  • Incidence of bleeding complications at 3-month follow-up.

    3 months

  • Percentage of patients with new-onset migraine attacks.

    3 months

  • Time to first migraine episode.

    3 months

  • Percentage of patients with migraine headaches at 6-month and 1-year follow-up (exploratory only according to local feasibility).

    1 year

Study Arms (2)

Aspirin + clopidogrel

EXPERIMENTAL

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

Drug: Clopidogrel

Aspirin

ACTIVE COMPARATOR

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

Drug: Clopidogrel

Interventions

ClopidogrelDRUG

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)
AspirinAspirin + clopidogrel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Laval

Québec, G1V 4G5, Canada

Location

Related Publications (2)

  • 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.

    PMID: 32965476DERIVED

  • 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.

    PMID: 26551304DERIVED

MeSH Terms

Conditions

Migraine DisordersHeart Septal Defects, Atrial

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Josep Rodes-Cabau, MD

    Hopital Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2008

First Posted

November 27, 2008

Study Start

October 1, 2008

Primary Completion

April 1, 2015

Study Completion

December 1, 2016

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

CA(1)