Clinical trial NCT05854992: Treatments of Migraine with Triptans in Individuals with Elevated Cardiovascular Risk and in Pregnant Women
Official title: Treatments of Migraine with Triptans in Individuals with Elevated Cardiovascular Risk and in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Cardiovascular Diseases
Pregnancy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2023-05-11
Enrollment: 68419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients were identified through Mayo Clinic electronic health records.

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.

Eligibility criteria: Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk:

Inclusion:

* 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.

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

Primary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: 60 days of starting treatment
measure: Full term birth
timeFrame: 39 0/7 weeks of gestation through 40 6/7 weeks of gestation
Secondary outcomes:
measure: all-cause death
timeFrame: 60 days of starting treatment
measure: Nonfatal myocardial infarction
timeFrame: 60 days of starting treatment
measure: Nonfatal stroke
timeFrame: 60 days of starting treatment
measure: Heart failure
timeFrame: 60 days of starting treatment
measure: Transient cerebral ischemia
timeFrame: 60 days of starting treatment
measure: Revascularization
timeFrame: 60 days of starting treatment
measure: Pre-term delivery
timeFrame: 37 0/7 weeks of gestation through 38 6/7 weeks of gestation
measure: Cesarean section delivery
timeFrame: up to delivery
measure: Spontaneous abortions/miscarriage
timeFrame: up to delivery
measure: Fetal death/stillbirth
timeFrame: up to delivery
measure: Intra-uterine growth restriction
timeFrame: up to delivery
measure: Eclampsia/preeclampsia
timeFrame: up to delivery
measure: Tubal or ectopic pregnancy
timeFrame: up to delivery
measure: Major fetal malformations
timeFrame: up to delivery
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mohammad Murad, MD
role: PRINCIPAL_INVESTIGATOR
References: