Aspirin Resistance in Women With Migraine

Summary

The purpose of this study is to compare the rates of aspirin resistance (high residual platelet reactivity) between women with episodic and chronic migraine and women without migraine.

Emerging evidence suggests that migraineurs, especially women \< 45 years who have aura, have an increased risk of stroke and myocardial infarction (MI, or heart attack). The mechanism linking migraine, stroke and MI is unclear although increased platelet activation and aggregation observed during and between migraine attacks may be a plausible theory.

Aspirin is an inexpensive, relatively safe antiplatelet drug that reduces the risk of stroke and MI. Preliminary data suggest that aspirin's (325mg) therapeutic effect on platelet inhibition may be reduced in migraineurs (i.e., aspirin resistance), thus limiting aspirin's effectiveness at preventing stroke and MI risks in persons with migraine. Additional research is warranted to confirm these findings in migraineurs because daily, low-dose aspirin 81 mg is the recommended first line therapy for primary and secondary prevention of stroke and MI

The researchers hypothesize that resistance to aspirin 81mg may occur more frequently in women with episodic and chronic migraine than in women without migraine. The findings may have important implications for women who have migraine and use aspirin to prevent migraine symptoms or comorbidities associated with migraine including stroke and MI.

Conditions

• Episodic Migraine
• Chronic Migraine

Interventions

DRUG

Aspirin (acetylsalicylic acid)

Aspirin one 81 mg capsule per day for 10-14 consecutive days

DRUG

Placebo

1 placebo capsule identical in appearance and excipient to aspirin capsule per day for 10-14 consecutive days

Sponsors & Collaborators

• University of Washington

  collaborator OTHER

• National Headache Foundation

  collaborator UNKNOWN

• Wadsworth Foundation

  collaborator UNKNOWN

• Accumetrics, Inc.

  collaborator INDUSTRY

• Swedish Medical Center

  lead OTHER

Principal Investigators

• Jill T. Jesurum, Ph.D. · Swedish Medical Center

• Cindy J. Fuller, Ph.D. · Swedish Medical Center

• Sylvia M. Lucas, MD, PhD · University of Washington

• Natalia Murinova, MD · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-11-30

Primary Completion

2011-10-31

Completion

2012-08-31

Countries

• United States

Study Locations