Treatments of Migraine with Triptans in Individuals with Elevated Cardiovascular Risk and in Pregnant Women
NCT ID: NCT05854992
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
68419 participants
OBSERVATIONAL
2022-07-05
2024-11-01
Brief Summary
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Detailed Description
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Triptans, the mainstay treatment for migraine attacks and the one supported by the highest quality evidence, are considered vasoactive and are contraindicated per formulary in individuals who have a history of myocardial infarction, stroke, or uncontrolled vascular risk factors such as hypertension. These individuals are usually excluded from randomized trials. Similarly, pregnant women have been excluded from triptans trials and the observational studies offered low certainty evidence about their safety. Yet, 44% of surveyed members of the American Headache Society reported being somewhat or very comfortable using triptans in pregnancy.
Therefore, the investigators intend to evaluate the safety of triptan treatment of migraine in individuals with cardiovascular disease or multiple cardiovascular risk factors, and in pregnant women in two target trial emulations.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Cardiovascular Risk Group Treated with Triptans
Subjects with diagnosis of migraine and cardiovascular disease, cerebrovascular disease and/or two or more cardiovascular risk factors who received Triptans as part of clinical care.
Acute migraine treatment with any prescribed triptans
Sumatriptan, treximet (sumatriptan/naproxen combination), zolmitriptan, naratriptan, rizatriptan, almotriptan, eletriptan, and frovatriptan. No restriction on dose, frequency, duration, or delivery routes.
Cardiovascular Risk Control Group Treated with No Triptans
Subjects with who did not received Triptans as part of clinical care.
Standard of care management of acute migraine without triptans
Any standard of care management without triptans
Pregnant Women Group Treated with Triptans
Subjects diagnosed with migraine that received Triptans as part of clinical care during pregnancy.
Acute migraine treatment with any prescribed triptans
Sumatriptan, treximet (sumatriptan/naproxen combination), zolmitriptan, naratriptan, rizatriptan, almotriptan, eletriptan, and frovatriptan. No restriction on dose, frequency, duration, or delivery routes.
Pregnant Women Control Group Treated with No Triptans
Subjects that did not receive Triptans as part of clinical care during pregnancy.
Standard of care management of acute migraine without triptans
Any standard of care management without triptans
Interventions
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Acute migraine treatment with any prescribed triptans
Sumatriptan, treximet (sumatriptan/naproxen combination), zolmitriptan, naratriptan, rizatriptan, almotriptan, eletriptan, and frovatriptan. No restriction on dose, frequency, duration, or delivery routes.
Standard of care management of acute migraine without triptans
Any standard of care management without triptans
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 1 year history of migraine with or without aura
* Confirmed cardiovascular or cerebrovascular disease, including myocardial infarction (MI), coronary artery disease (CAD), cerebrovascular disease, stroke; or at least 2 cardiovascular risk factors, including diabetes, hyperlipidemia, hypertension, obstructive sleep apnea, peripheral vascular disease;
* At least 1 year of prior triptan treatment or no previous triptan treatment.
Exclusion:
• Prescription of ergot alkaloids or dihydroergotamine within 60 days before or after starting treatment
Treatments of Migraine With Triptans in Pregnant Women
Inclusion:
* Aged \>=18 years
* Pregnant woman
* Diagnosis of episodic or chronic migraine with or without aura before pregnancy
Exclusion:
• Prescription of ergot alkaloids or dihydroergotamine \<= 60 days before pregnancy or during pregnancy
18 Years
ALL
No
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
Mayo Clinic
OTHER
Responsible Party
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M. Hassan Murad, M.D.
Principal Investigator
Principal Investigators
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Mohammad Murad, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Arizona
Phoenix, Arizona, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Mayo Clinic Minnesota
Rochester, Minnesota, United States
Countries
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References
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Wang Z, VanderPluym JH, Halker Singh RB, Alsibai RA, Roellinger DL, Murad MH. Safety of Triptans in Treating Migraines in Pregnant Women: A Target Trial Emulation. Mayo Clin Proc. 2025 Jul 28:S0025-6196(25)00105-3. doi: 10.1016/j.mayocp.2025.01.023. Online ahead of print.
Wang Z, VanderPluym JH, Halker Singh RB, Alsibai RA, Roellinger DL, Firwana M, Murad MH. Safety of Triptans in Patients Who Have or Are at High Risk for Cardiovascular Disease: A Target Trial Emulation. Mayo Clin Proc. 2024 Nov;99(11):1722-1731. doi: 10.1016/j.mayocp.2024.03.023. Epub 2024 Aug 30.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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22-005920
Identifier Type: -
Identifier Source: org_study_id