| Conditions: |
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Episodic Migraine - Chronic Migraine |
| Purpose: |
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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.
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| Study Summary: |
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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
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| Criteria: |
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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-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.
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| NCT ID: |
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NCT01257893 |
| Primary Contact: |
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Principal Investigator
Jill T. Jesurum, Ph.D.
Swedish Medical Center
Jill T. Jesurum, Ph.D.
Phone: 206-386-6290
Email: jill.jesurum@swedish.org
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| Backup Contact: |
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Email: emcgee@uw.edu
Elisa A. McGee, B.S.
Phone: 206-598-9260
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| Location Contact: |
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Seattle, Washington 98195
United States
Elisa A. McGee, B.S.
Phone: 206-598-9260
Email: emcgee@uw.edu
Site Status: Recruiting |