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

Mayo Clinic

Status: Completed

Conditions: Cardiovascular Diseases; Migraine; Pregnancy

Treatments: Drug: Standard of care management of acute migraine without triptans; Drug: Acute migraine treatment with any prescribed triptans

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05854992

22-005920

Details and patient eligibility

About

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

Full 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.

Enrollment: 68,419 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

68,419 participants in 4 patient groups

Cardiovascular Risk Group Treated with Triptans

Description:

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.

Treatment:

Drug: Acute migraine treatment with any prescribed triptans

Cardiovascular Risk Control Group Treated with No Triptans

Description:

Subjects with who did not received Triptans as part of clinical care.

Treatment:

Drug: Standard of care management of acute migraine without triptans

Pregnant Women Group Treated with Triptans

Description:

Subjects diagnosed with migraine that received Triptans as part of clinical care during pregnancy.

Treatment:

Drug: Acute migraine treatment with any prescribed triptans

Pregnant Women Control Group Treated with No Triptans

Description:

Subjects that did not receive Triptans as part of clinical care during pregnancy.

Treatment:

Drug: Standard of care management of acute migraine without triptans