Status:
WITHDRAWN
Aspirin Resistance in Women With Migraine
Lead Sponsor:
Swedish Medical Center
Collaborating Sponsors:
University of Washington
National Headache Foundation
Conditions:
Episodic Migraine
Chronic Migraine
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief 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 evide...
Detailed Description
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-contr...
Eligibility Criteria
Inclusion
- 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
- 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-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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01257893
Start Date
November 1 2010
End Date
August 1 2012
Last Update
May 31 2013
Active Locations (1)
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1
The University of Washington
Seattle, Washington, United States, 98195