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

Phase 4

Completed

• Conditions: Migraine
• Interventions: Drug: Clopidogrel

• Registration Number: NCT00799045
• Lead Sponsor: Laval University

Brief Summary

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

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 Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2008-11-26
• Study First Posted: 2008-11-27
• Primary Completion: 2015-04
• Study Completion: 2016-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Hopital Laval; 🇨🇦 Quebec, Canada