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AzTrials

MigraineNCT05854992

Treatments of Migraine with Triptans in Individuals with Elevated Cardiovascular Risk and in Pregnant Women

An observational study of Migraine and Cardiovascular Diseases, run by Mayo Clinic at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Researchers are evaluating the safety of triptan treatment of migraine in individuals with elevated cardiovascular risk and in pregnant women. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine, Cardiovascular Diseases, Pregnancy
What is being tested?
Acute migraine treatment with any prescribed triptans
How many people
68,419 participants
Where
3 sitesUnited States
Study dates
5 Jul 2022to 1 Nov 2024
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Eligible patients were identified through Mayo Clinic electronic health records.

Who may be able to join

  • 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.
  • Aged >=18 years
  • Pregnant woman
  • Diagnosis of episodic or chronic migraine with or without aura before pregnancy

Who cannot join

  • Prescription of ergot alkaloids or dihydroergotamine within 60 days before or after starting treatment
  • Treatments of Migraine With Triptans in Pregnant Women
  • Prescription of ergot alkaloids or dihydroergotamine <= 60 days before pregnancy or during pregnancy

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • Mayo Clinic Minnesota

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Researchers are evaluating the safety of triptan treatment of migraine in individuals with elevated cardiovascular risk and in pregnant women.

Read the detailed description

Migraine is a very common condition that can be associated with significant morbidity. For the acute treatment of migraine attacks, the use of triptans, NSAIDs, acetaminophen, dihydroergotamine, calcitonin gene-related peptide antagonists, lasmiditan, and some nonpharmacologic treatments are associated with improved pain and function. The effectiveness of these therapies has been documented in various studies and summarized in systematic reviews. However, systematic reviews have demonstrated evidence gaps in two groups of patients that were excluded from treatment trials. These are patients with cardiovascular disease or at high risk of cardiovascular events, and pregnant women.

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.

Being tested
Acute migraine treatment with any prescribed triptans, Standard of care management of acute migraine without triptans
Medical subject headings
Migraine Disorders, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acute migraine treatment with any prescribed triptansDrug

    Also called 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 triptansDrug

    Also called No triptans

    Any standard of care management without triptans

Study groups in NCT05854992
Study groupRoleWhat they receive
Cardiovascular Risk Group Treated with TriptansSubjects 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.
Receives: Drug: Acute migraine treatment with any prescribed triptans
Cardiovascular Risk Control Group Treated with No TriptansSubjects with who did not received Triptans as part of clinical care.
Receives: Drug: Standard of care management of acute migraine without triptans
Pregnant Women Group Treated with TriptansSubjects diagnosed with migraine that received Triptans as part of clinical care during pregnancy.
Receives: Drug: Acute migraine treatment with any prescribed triptans
Pregnant Women Control Group Treated with No TriptansSubjects that did not receive Triptans as part of clinical care during pregnancy.
Receives: Drug: Standard of care management of acute migraine without triptans

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 60 days of starting treatment

  2. Full term birth

    Treatments of Migraine With Triptans in Pregnant Women: number of pregnant women to have a full term birth

    Measured: 39 0/7 weeks of gestation through 40 6/7 weeks of gestation

Secondary outcomes (14)

  1. all-cause death

    Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: all-cause death

    Measured: 60 days of starting treatment

  2. Nonfatal myocardial infarction

    Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: nonfatal myocardial infarction

    Measured: 60 days of starting treatment

  3. Nonfatal stroke

    Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: nonfatal stroke

    Measured: 60 days of starting treatment

  4. Heart failure

    Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: Heart failure

    Measured: 60 days of starting treatment

  5. Transient cerebral ischemia

    Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: transient cerebral ischemia

    Measured: 60 days of starting treatment

  6. Revascularization

    Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: revascularization

    Measured: 60 days of starting treatment

  7. Pre-term delivery

    Treatments of Migraine With Triptans in Pregnant Women: Pre-term delivery

    Measured: 37 0/7 weeks of gestation through 38 6/7 weeks of gestation

  8. Cesarean section delivery

    Treatments of Migraine With Triptans in Pregnant Women: cesarean section delivery

    Measured: up to delivery

  9. Spontaneous abortions/miscarriage

    Treatments of Migraine With Triptans in Pregnant Women: Spontaneous abortions/miscarriage

    Measured: up to delivery

  10. Fetal death/stillbirth

    Treatments of Migraine With Triptans in Pregnant Women: Fetal death/stillbirth

    Measured: up to delivery

  11. Intra-uterine growth restriction

    Treatments of Migraine With Triptans in Pregnant Women: Intra-uterine growth restriction

    Measured: up to delivery

  12. Eclampsia/preeclampsia

    Treatments of Migraine With Triptans in Pregnant Women: Eclampsia/preeclampsia

    Measured: up to delivery

  13. Tubal or ectopic pregnancy

    Treatments of Migraine With Triptans in Pregnant Women: Tubal or ectopic pregnancy

    Measured: up to delivery

  14. Major fetal malformations

    Treatments of Migraine With Triptans in Pregnant Women: Major fetal malformations

    Measured: up to delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start5 Jul 2022
  3. Primary completion1 Nov 2024
  4. Study completion1 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
68,419 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05854992
Sponsor's protocol ID
22-005920
Status last verified
Nov 2024
First submitted
3 May 2023
Last updated
2 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40719668

  • 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.

    PubMed 39207344

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine and Cardiovascular Diseases, run by Mayo Clinic at 3 sites 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Major adverse cardiovascular events (MACE) (time frame: 60 days of starting treatment). The study lists 2 primary outcomes in all. 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 NCT05854992, 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 2 Dec 2024.

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