Episodic MigraineARWMNCT01257893
Aspirin Resistance in Women With Migraine
A study testing Aspirin (acetylsalicylic acid) in people with Episodic Migraine and Chronic Migraine, run by Swedish Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episodic Migraine, Chronic Migraine
- What is being tested?
- Aspirin (acetylsalicylic acid)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Washington
Seattle, Washington, 98195
About this study
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.
Read more
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.
Read the 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
- Conditions
- Episodic Migraine, Chronic Migraine
- Being tested
- Aspirin (acetylsalicylic acid), Placebo
- Keywords
- migraine, chronic migraine, migraine with aura, migraine without aura, aspirin, platelets
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin (acetylsalicylic acid)Drug
Aspirin one 81 mg capsule per day for 10-14 consecutive days
PlaceboDrug
1 placebo capsule identical in appearance and excipient to aspirin capsule per day for 10-14 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Aspirin 81 mg | Experimental | Subjects will take 81 mg aspirin per day for 10-14 consecutive days Receives: Drug: Aspirin (acetylsalicylic acid) |
| Placebo | Placebo comparator | Subjects will take matching placebo capsule (excipient: methylcellulose) for 10-14 consecutive days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aspirin Reaction Units (ARU)
Measurement of ARU, indicative of platelet inhibition, using the VerifyNow Aspirin Assay (Accumetrics, San Diego, CA)
Measured: 10-14 days
Secondary outcomes (1)
Serum thromboxane B2
Aspirin acts by inhibiting production of thromboxane A2 by platelets. Thromboxane B2 is the stable product of thromboxane A2.
Measured: 10-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Episodic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, National Headache Foundation, Wadsworth Foundation, Accumetrics, Inc.
- Investigators
- Jill T. Jesurum, Ph.D., Principal investigator, Swedish Medical CenterCindy J. Fuller, Ph.D., Study director, Swedish Medical CenterSylvia M. Lucas, MD, PhD, Study chair, University of WashingtonNatalia Murinova, MD, Study chair, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257893
- Sponsor's protocol ID
- 4959S-10
- Acronym
- ARWM
- Status last verified
- May 2013
- First submitted
- 8 Dec 2010
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin Resistance in Women With Migraine
- ClinicalTrials.gov ID
- NCT01257893
- Acronym / sponsor ID
- ARWM / 4959S-10
- Conditions
- Episodic Migraine, Chronic Migraine
- Keywords
- migraine, chronic migraine, migraine with aura, migraine without aura, aspirin, platelets
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Collaborators
- University of Washington, National Headache Foundation, Wadsworth Foundation, Accumetrics, Inc.
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin 81 mg | Experimental | Drug: Aspirin (acetylsalicylic acid)Subjects will take 81 mg aspirin per day for 10-14 consecutive days |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will take matching placebo capsule (excipient: methylcellulose) for 10-14 consecutive days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin (acetylsalicylic acid)Aspirin one 81 mg capsule per day for 10-14 consecutive days | Drug | Aspirin 81 mg |
| Placebo1 placebo capsule identical in appearance and excipient to aspirin capsule per day for 10-14 consecutive days | Drug | Placebo |
Primary outcome
Aspirin Reaction Units (ARU)
Time frame: 10-14 days
Measurement of ARU, indicative of platelet inhibition, using the VerifyNow Aspirin Assay (Accumetrics, San Diego, CA)
1 secondary outcome
Serum thromboxane B2
Time frame: 10-14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
- BackgroundJesurum, 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.
- BackgroundJesurum, 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill T. Jesurum, Ph.D. principal investigator
Swedish Medical Center
Cindy J. Fuller, Ph.D. study director
Swedish Medical Center
Sylvia M. Lucas, MD, PhD study chair
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin (acetylsalicylic acid) in people with Episodic Migraine and Chronic Migraine, run by Swedish Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aspirin Reaction Units (ARU) (time frame: 10-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01257893, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2013.