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

Migraine Clinical Trial

— CANOA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799045
• Other study ID #: CLOPI_L_03563
• Status: Completed
• Phase: Phase 4
• Start date: October 2008
• Est. completion date: December 2016

Study information

• Verified date: February 2019
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Heart Septal Defects
• Heart Septal Defects, Atrial
• Migraine
• Migraine Disorders

Intervention

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.

Locations

Country	Name	City	State
Canada	Hopital Laval	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	Bristol-Myers Squibb, Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of monthly migraine days per patient within the 3 months following transcatheter ASD closure.		3 months
Secondary	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
Secondary	Incidence of bleeding complications at 3-month follow-up.		3 months
Secondary	Percentage of patients with new-onset migraine attacks.		3 months
Secondary	Time to first migraine episode.		3 months
Secondary	Percentage of patients with migraine headaches at 6-month and 1-year follow-up (exploratory only according to local feasibility).		1 year