Aspirin Resistance in Women With Migraine

NCT01257893 | Withdrawn

• 1 other identifier: 4959S-10
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Episodic Migraine; Chronic Migraine

Keywords

migraine; chronic migraine; migraine with aura; migraine without aura; aspirin; platelets

Outcome Measures

Primary Outcomes (1)

• Aspirin Reaction Units (ARU)

  Measurement of ARU, indicative of platelet inhibition, using the VerifyNow Aspirin Assay (Accumetrics, San Diego, CA)

  10-14 days

Secondary Outcomes (1)

• Serum thromboxane B2

  10-14 days

Study Arms (2)

Aspirin 81 mg

EXPERIMENTAL

Subjects will take 81 mg aspirin per day for 10-14 consecutive days

Drug: Aspirin (acetylsalicylic acid)

Placebo

PLACEBO COMPARATOR

Subjects will take matching placebo capsule (excipient: methylcellulose) for 10-14 consecutive days.

Drug: Placebo

Interventions

Aspirin (acetylsalicylic acid) DRUG

Aspirin one 81 mg capsule per day for 10-14 consecutive days

Aspirin 81 mg

Placebo DRUG

1 placebo capsule identical in appearance and excipient to aspirin capsule per day for 10-14 consecutive days

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swedish Medical Center: lead
• University of Washington: collaborator
• National Headache Foundation: collaborator
• Wadsworth Foundation: collaborator
• Accumetrics, Inc.: collaborator

Study Sites (1)

The University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Migraine with Aura; Migraine without Aura

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jill T. Jesurum, Ph.D.

  Swedish Medical Center

  PRINCIPAL INVESTIGATOR

• Cindy J. Fuller, Ph.D.

  Swedish Medical Center

  STUDY DIRECTOR

• Sylvia M. Lucas, MD, PhD

  University of Washington

  STUDY CHAIR

• Natalia Murinova, MD

  University of Washington

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 10, 2010
• Study Start: November 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: August 1, 2012
• Last Updated: May 31, 2013

Record last verified: 2013-05

Locations

US (1)