WithdrawnNot Applicable

Aspirin Resistance in Women With Migraine

United States0Started 2010-11

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women 18-50 years of age, of childbearing potential * Able to read, speak, and understand English -- except if patient is blind, in which case only the ability to understand English is required. Episodic Migraine Group: * Documented diagnosis of episodic migraine for a 2-year period preceding enrollment, using the International Headache Society (IHS) criteria. * Frequency of 2-14 migraine days in the three months prior to enrollment. * Equal numbers (n=20 each) will have a documented diagnosis of migraine with aura (MA) and migraine without aura (MO). * For women who have a diagnosis of MA, focal neurologic symptoms must precede or accompany the headache (aura) for at least one headache in the 12 months prior to enrollment. Chronic Migraine Group: * Frequency of ≥ 15 headache days per month for ≥ 3 months. * On at least 8 days per month for ≥ 3 months headache has fulfilled criteria for pain and associated symptoms of MO. Control group: \- No diagnosis of migraine, confirmed by the Migraine Assessment Tool. Exclusion Criteria: * Pregnancy or lactation * Post-menopausal, either natural or surgical (bilateral oophorectomy) * Current prescribed daily medication regimen includes any of the following: warfarin, glycoprotein IIb/IIIa inhibitors (abciximab, tirofiban), antiplatelet agents (clopidogrel, ticlopidine, dipyridamole), or non-steroidal anti-inflammatory drugs (e.g., ibuprofen, naproxen, celecoxib), Vitamin E in doses \> 800 IU per day, Omega…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Aspirin Reaction Units (ARU)

Timeframe: 10-14 days

Trial details

NCT IDNCT01257893

SponsorSwedish Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-10

View on ClinicalTrials.gov More Episodic Migraine trials