Treatments of Migraine with Triptans in Individuals with Elevated Cardiovascular Risk and in Pregnant Women
- Conditions
- Cardiovascular DiseasesPregnancyMigraine
- Interventions
- Drug: Acute migraine treatment with any prescribed triptansDrug: Standard of care management of acute migraine without triptans
- Registration Number
- NCT05854992
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Researchers are evaluating the safety of triptan treatment of migraine in individuals with elevated cardiovascular risk and in pregnant women.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68419
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cardiovascular Risk Group Treated with Triptans Acute migraine treatment with any prescribed 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 Standard of care management of acute migraine without triptans Subjects with who did not received Triptans as part of clinical care. Pregnant Women Group Treated with Triptans Acute migraine treatment with any prescribed triptans Subjects diagnosed with migraine that received Triptans as part of clinical care during pregnancy. Pregnant Women Control Group Treated with No Triptans Standard of care management of acute migraine without triptans Subjects that did not receive Triptans as part of clinical care during pregnancy.
- Primary Outcome Measures
Name Time Method Major adverse cardiovascular events (MACE) 60 days of starting treatment 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
Full term birth 39 0/7 weeks of gestation through 40 6/7 weeks of gestation Treatments of Migraine With Triptans in Pregnant Women: number of pregnant women to have a full term birth
- Secondary Outcome Measures
Name Time Method Heart failure 60 days of starting treatment Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: Heart failure
Revascularization 60 days of starting treatment Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: revascularization
Pre-term delivery 37 0/7 weeks of gestation through 38 6/7 weeks of gestation Treatments of Migraine With Triptans in Pregnant Women: Pre-term delivery
all-cause death 60 days of starting treatment Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: all-cause death
Nonfatal stroke 60 days of starting treatment Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: nonfatal stroke
Nonfatal myocardial infarction 60 days of starting treatment Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: nonfatal myocardial infarction
Transient cerebral ischemia 60 days of starting treatment Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: transient cerebral ischemia
Tubal or ectopic pregnancy up to delivery Treatments of Migraine With Triptans in Pregnant Women: Tubal or ectopic pregnancy
Fetal death/stillbirth up to delivery Treatments of Migraine With Triptans in Pregnant Women: Fetal death/stillbirth
Cesarean section delivery up to delivery Treatments of Migraine With Triptans in Pregnant Women: cesarean section delivery
Spontaneous abortions/miscarriage up to delivery Treatments of Migraine With Triptans in Pregnant Women: Spontaneous abortions/miscarriage
Intra-uterine growth restriction up to delivery Treatments of Migraine With Triptans in Pregnant Women: Intra-uterine growth restriction
Eclampsia/preeclampsia up to delivery Treatments of Migraine With Triptans in Pregnant Women: Eclampsia/preeclampsia
Major fetal malformations up to delivery Treatments of Migraine With Triptans in Pregnant Women: Major fetal malformations
Trial Locations
- Locations (3)
Mayo Clinic Minnesota
🇺🇸Rochester, Minnesota, United States
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States