Aspirin Resistance in Women with Migraine

Aspirin Resistance in Women with Migraine

Type of Study
Headache/Migraine - Headache/Migraine
Location
Cherry Hill Campus
Short Description

Women who have migraine, especially those with aura and high headache frequency, have an increased risk of stroke.  Women who have migraine may have high platelet activity on aspirin treatment.  Therefore, further research is needed to confirm the effect of aspirin on platelet inhibition in women with migraine.  Thus, the purpose of this study is to determine the prevalence of aspirin resistance in women with migraine following 10-14 consecutive days of aspirin 81mg treatment.  Women with migraine (40; 20 each with and without aura) and without migraine (30) will be enrolled in a randomized, double-blind, placebo-controlled, crossover study to compare the effect of aspirin 81 mg on platelet function.  The findings may have important implications in managing women who have migraine and the use of antiplatelet therapy to prevent stroke and heart attack, particularly in those who have aura, and necessitate the need to explore adjunct, combination, or alternative antiplatelet therapy.

Status
Submitted for Study Approval
Principal Investigator
Jill Jesurum, PhD
Eligibility Notes

Inclusion Criteria:

1.  Women 18-50 years of age, with childbearing potential

2.  For the experimental (migraine group), documented diagnosis of migraine for a 2-year period preceding enrollment, confirmed by a neurology healthcare provider (MD, DO, ARNP, PA-C) using the International Headache Society criteria. 

3.  Migraineurs will have 2-14 migraine days in the three months prior to enrollment.  Equal numbers (n=20 each) will have MA and MO.

4.  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.

5.  The control group will have answers on the Migraine Assessment Test (MAT) consistent with a negative diagnosis of migraine.

6.  Able to read, speak, and understand English -- except if patient is blind, in which case only the ability to understand English is required.

Exclusion Criteria:

1.  Pregnancy

2.  Lactation

3.  Post-menopausal, either natural or surgical (bilateral oophorectomy)

4.  Diagnosis of chronic daily headache or medication-overuse headache.

5.  Current prescribed daily medication regimen includes any of the following:  warfarin, glycoprotein IIb/IIIa inhibitors (abciximab, tirofiban), antiplatelet agents (clopidogrel, ticlopidine, dipyridamole), COX-1 (e.g., iboprofen, naproxen) or COX-2 inhibitors (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, unless documentation of clinical evaluation to discontinue restricted medications and/or supplements for the duration of study participation has been provided by health care provider.

6.  Documented or known contraindication to aspirin treatment (e.g., intolerance, allergy, peptic ulcer disease).

7.  Platelet count <150,000/µl or >450,000/µl.

8.  Hemoglobin <10 g/dL.

9.  History or current diagnosis of myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, diabetes mellitus, or renal disease.

10. Unable to tolerate washout of protocol-restricted medications and/or supplements.

11. Family (first-degree relative) or patient history of bleeding or hemorrhagic disorders including von Willebrand Factor Deficiency, Glanzmann Thrombasthenia, Bernard-Soulier Syndrome.

12. Myeloproliferative syndromes.

13. Major surgical procedure, trauma, blood donation, or major blood loss (>300 cc) within 30 days prior to enrollment.

Contact Name
Dr. Cindy Fuller
Phone
206-320-3919
Alternate Phone
206-598-6950
Email
cindy.fuller@swedish.org
Alternate Email
emcgee@u.washington.edu