Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2010-11-30
2012-08-31
Brief Summary
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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.
Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SCREENING
DOUBLE
Study Groups
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Aspirin 81 mg
Subjects will take 81 mg aspirin per day for 10-14 consecutive days
Aspirin (acetylsalicylic acid)
Aspirin one 81 mg capsule per day for 10-14 consecutive days
Placebo
Subjects will take matching placebo capsule (excipient: methylcellulose) for 10-14 consecutive days.
Placebo
1 placebo capsule identical in appearance and excipient to aspirin capsule per day for 10-14 consecutive days
Interventions
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Aspirin (acetylsalicylic acid)
Aspirin one 81 mg capsule per day for 10-14 consecutive days
Placebo
1 placebo capsule identical in appearance and excipient to aspirin capsule per day for 10-14 consecutive days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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-3 fatty acids in doses \> 3 g/day, willow bark (any amount), aspirin or aspirin-containing medications.
* Aspirin intolerance or allergy, or peptic ulcer disease.
* Platelet count \<150,000/µl or \>450,000/µl.
* Hemoglobin \<10 g/dL.
* History or current diagnosis of myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, diabetes mellitus, or renal disease.
* Unable to tolerate washout of protocol-restricted medications and/or supplements (see #3).
* Family (first-degree relative) or patient history of bleeding or hemorrhagic disorders including von Willebrand Factor Deficiency, Glanzmann Thrombasthenia, Bernard-Soulier Syndrome or myeloproliferative syndromes.
* Major surgical procedure, trauma, blood donation, or major blood loss (\>300 cc) within 30 days prior to enrollment.
18 Years
50 Years
FEMALE
Yes
Sponsors
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University of Washington
OTHER
National Headache Foundation
UNKNOWN
Wadsworth Foundation
UNKNOWN
Accumetrics, Inc.
INDUSTRY
Swedish Medical Center
OTHER
Responsible Party
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Swedish Medical Center
Principal Investigators
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Jill T. Jesurum, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Swedish Medical Center
Cindy J. Fuller, Ph.D.
Role: STUDY_DIRECTOR
Swedish Medical Center
Sylvia M. Lucas, MD, PhD
Role: STUDY_CHAIR
University of Washington
Natalia Murinova, MD
Role: STUDY_CHAIR
University of Washington
Locations
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The University of Washington
Seattle, Washington, United States
Countries
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References
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Jesurum, J.T., Fuller, C.J., Lucas, S.M., Murinova, N., Truva, C.M., McGee, E.A., Reisman, M. High prevalence of aspirin resistance in migraineurs. Cephalalgia 2009; 29 (Suppl. 1): 138.
Jesurum, J.T., Fuller, C.J., Lucas, S.M., Murinova, N., Hales, L.E., McGee, E.A. The association between migraine frequency and platelet activation in episodic migraine: a pilot study. Cephalalgia 2009; 29 (Suppl. 1); 2009.
Other Identifiers
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4959S-10
Identifier Type: -
Identifier Source: org_study_id