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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2016-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aspirin + clopidogrel

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

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

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.

Aspirin

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

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Clopidogrel (Plavix)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No