Aspirin Resistance in Women With Migraine (ARWM)
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.
Drug: Aspirin (acetylsalicylic acid)
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Screening
|Official Title:||Aspirin Resistance in Women With Migraine|
- Aspirin Reaction Units (ARU) [ Time Frame: 10-14 days ] [ Designated as safety issue: No ]Measurement of ARU, indicative of platelet inhibition, using the VerifyNow Aspirin Assay (Accumetrics, San Diego, CA)
- Serum thromboxane B2 [ Time Frame: 10-14 days ] [ Designated as safety issue: No ]Aspirin acts by inhibiting production of thromboxane A2 by platelets. Thromboxane B2 is the stable product of thromboxane A2.
|Study Start Date:||November 2010|
|Study Completion Date:||August 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: Aspirin 81 mg
Subjects will take 81 mg aspirin per day for 10-14 consecutive days
Drug: Aspirin (acetylsalicylic acid)
Aspirin one 81 mg capsule per day for 10-14 consecutive days
Placebo Comparator: Placebo
Subjects will take matching placebo capsule (excipient: methylcellulose) for 10-14 consecutive days.
1 placebo capsule identical in appearance and excipient to aspirin capsule per day for 10-14 consecutive days
To test the hypothesis that the rate of aspirin resistance is greater in women with episodic and chronic migraine than in women without migraine, a three-group, randomized, double-blind, placebo-controlled, crossover design will be used to test the effects of aspirin 81 mg on platelet reactivity. Subjects will be randomized to treatment order (A) aspirin 81 mg for 10-14 consecutive days followed by placebo for 10-14 consecutive days or (B) placebo for 10-14 consecutive days followed by aspirin 81 mg for 10-14 consecutive days. Other than treatment order, subjects will be treated equally. Study procedures will be performed at the University of Washington, and the duration of the study per subject will be approximately 28 days. Endpoints include: a) Aspirin Reaction Units (ARU) using a point-of-care assay (VerifyNow Aspirin™; Accumetrics, San Diego, CA); b) serum thromboxane B2; and c) percent platelet inhibition on aspirin. Assessment of adherence to study regimen will be assessed by serum salicylate, medication diaries, and pill counts. Data will also be collected on migraine frequency, burden, disability, and medications used to treat headache. Subjects will maintain a migraine diary for the duration of the study (28 days). The target sample will include women with episodic migraine (n=40; n=20 MA, n=20 MO), women with chronic migraine (n=40) and non-migraine controls (n=40).
The specific aims of the study are as follows:
- Compare the rate of aspirin resistance between women with and without migraine following 10-14 consecutive days of aspirin 81 mg treatment
- Compare the rate of aspirin resistance between women who have episodic migraine and chronic migraine following 10-14 consecutive days of aspirin 81 mg treatment
- Compare the rate of aspirin resistance between women who have migraine with aura (MA) and migraine without aura (MO) following 10-14 consecutive days of aspirin 81 mg or placebo treatment
- Compare the rate of aspirin resistance between women who have migraine with high monthly migraine frequency and low monthly migraine frequency following 10-14 consecutive days of aspirin 81 mg treatment
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257893
|United States, Washington|
|The University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Jill T. Jesurum, Ph.D.||Swedish Medical Center|
|Study Director:||Cindy J. Fuller, Ph.D.||Swedish Medical Center|
|Study Chair:||Sylvia M. Lucas, MD, PhD||University of Washington|
|Study Chair:||Natalia Murinova, MD||University of Washington|