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Aspirin Resistance in Women With Migraine (ARWM)

Primary Purpose

Episodic Migraine, Chronic Migraine

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Aspirin (acetylsalicylic acid)

Placebo

About this trial

This is an interventional screening trial for Episodic Migraine focused on measuring migraine, chronic migraine, migraine with aura, migraine without aura, aspirin, platelets

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

The University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aspirin 81 mg

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Aspirin Reaction Units (ARU)

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

Secondary Outcome Measures

Serum thromboxane B2

Aspirin acts by inhibiting production of thromboxane A2 by platelets. Thromboxane B2 is the stable product of thromboxane A2.

Full Information

NCT ID

NCT01257893

First Posted

December 8, 2010

Last Updated

May 29, 2013

Sponsor

Swedish Medical Center

Collaborators

University of Washington, National Headache Foundation, Wadsworth Foundation, Accumetrics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01257893

Brief Title

Aspirin Resistance in Women With Migraine

Acronym

ARWM

Official Title

Aspirin Resistance in Women With Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Withdrawn

Study Start Date

November 2010 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Swedish Medical Center

Collaborators

University of Washington, National Headache Foundation, Wadsworth Foundation, Accumetrics, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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-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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Episodic Migraine, Chronic Migraine

Keywords

migraine, chronic migraine, migraine with aura, migraine without aura, aspirin, platelets

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aspirin 81 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Aspirin (acetylsalicylic acid)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Aspirin Reaction Units (ARU)

Description

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

Time Frame

10-14 days

Secondary Outcome Measure Information:

Title

Serum thromboxane B2

Description

Aspirin acts by inhibiting production of thromboxane A2 by platelets. Thromboxane B2 is the stable product of thromboxane A2.

Time Frame

10-14 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jill T. Jesurum, Ph.D.

Organizational Affiliation

Swedish Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Cindy J. Fuller, Ph.D.

Organizational Affiliation

Swedish Medical Center

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Sylvia M. Lucas, MD, PhD

Organizational Affiliation

University of Washington

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Natalia Murinova, MD

Organizational Affiliation

University of Washington

Official's Role

Study Chair

Facility Information:

Facility Name

The University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

12. IPD Sharing Statement

Citations:

Citation

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.

Results Reference

background

Citation

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.

Results Reference

background

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Aspirin Resistance in Women With Migraine

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