Treatments of Migraine with Triptans in Individuals with Elevated Cardiovascular Risk and in Pregnant Women
1 other identifier
observational
68,419
1 country
3
Brief Summary
Researchers are evaluating the safety of triptan treatment of migraine in individuals with elevated cardiovascular risk and in pregnant women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2022
CompletedFirst Submitted
Initial submission to the registry
May 3, 2023
CompletedFirst Posted
Study publicly available on registry
May 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedDecember 2, 2024
November 1, 2024
2.3 years
May 3, 2023
November 25, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Major adverse cardiovascular events (MACE)
Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: number of subjects to experience major adverse cardiovascular events (MACE) which consists of all-cause death, nonfatal myocardial infarction, nonfatal stroke, heart failure, transient cerebral ischemia, or revascularization
60 days of starting treatment
Full term birth
Treatments of Migraine With Triptans in Pregnant Women: number of pregnant women to have a full term birth
39 0/7 weeks of gestation through 40 6/7 weeks of gestation
Secondary Outcomes (14)
all-cause death
60 days of starting treatment
Nonfatal myocardial infarction
60 days of starting treatment
Nonfatal stroke
60 days of starting treatment
Heart failure
60 days of starting treatment
Transient cerebral ischemia
60 days of starting treatment
- +9 more secondary outcomes
Study Arms (4)
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.
Cardiovascular Risk Control Group Treated with No Triptans
Subjects with who did not received Triptans as part of clinical care.
Pregnant Women Group Treated with Triptans
Subjects diagnosed with migraine that received Triptans as part of clinical care during pregnancy.
Pregnant Women Control Group Treated with No Triptans
Subjects that did not receive Triptans as part of clinical care during pregnancy.
Interventions
Sumatriptan, treximet (sumatriptan/naproxen combination), zolmitriptan, naratriptan, rizatriptan, almotriptan, eletriptan, and frovatriptan. No restriction on dose, frequency, duration, or delivery routes.
Any standard of care management without triptans
Eligibility Criteria
Eligible patients were identified through Mayo Clinic electronic health records.
You may qualify if:
- Aged \>=18 years
- 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.
You may not qualify if:
- Prescription of ergot alkaloids or dihydroergotamine within 60 days before or after starting treatment
- Treatments of Migraine With Triptans in Pregnant Women
- Aged \>=18 years
- Pregnant woman
- Diagnosis of episodic or chronic migraine with or without aura before pregnancy
- Prescription of ergot alkaloids or dihydroergotamine \<= 60 days before pregnancy or during pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Agency for Healthcare Research and Quality (AHRQ)collaborator
Study Sites (3)
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Mayo Clinic Minnesota
Rochester, Minnesota, 55905, United States
Related Publications (2)
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 Nov;100(11):1956-1962. doi: 10.1016/j.mayocp.2025.01.023. Epub 2025 Jul 28.
PMID: 40719668DERIVEDWang 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.
PMID: 39207344DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohammad Murad, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 3, 2023
First Posted
May 11, 2023
Study Start
July 5, 2022
Primary Completion
November 1, 2024
Study Completion
November 1, 2024
Last Updated
December 2, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share