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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05854992
• Other study ID #: 22-005920
• Status: Active, not recruiting
• Start date: July 5, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 68419
• Est. completion date: December 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Migraine
• Migraine Disorders
• Pregnancy

Intervention

Drug:
• Acute migraine treatment with any prescribed 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 triptans
Any standard of care management without triptans

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	all-cause death	Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: all-cause death	60 days of starting treatment
Secondary	Nonfatal myocardial infarction	Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: nonfatal myocardial infarction	60 days of starting treatment
Secondary	Nonfatal stroke	Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: nonfatal stroke	60 days of starting treatment
Secondary	Heart failure	Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: Heart failure	60 days of starting treatment
Secondary	Transient cerebral ischemia	Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: transient cerebral ischemia	60 days of starting treatment
Secondary	Revascularization	Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: revascularization	60 days of starting treatment
Secondary	Pre-term delivery	Treatments of Migraine With Triptans in Pregnant Women: Pre-term delivery	37 0/7 weeks of gestation through 38 6/7 weeks of gestation
Secondary	Cesarean section delivery	Treatments of Migraine With Triptans in Pregnant Women: cesarean section delivery	up to delivery
Secondary	Spontaneous abortions/miscarriage	Treatments of Migraine With Triptans in Pregnant Women: Spontaneous abortions/miscarriage	up to delivery
Secondary	Fetal death/stillbirth	Treatments of Migraine With Triptans in Pregnant Women: Fetal death/stillbirth	up to delivery
Secondary	Intra-uterine growth restriction	Treatments of Migraine With Triptans in Pregnant Women: Intra-uterine growth restriction	up to delivery
Secondary	Eclampsia/preeclampsia	Treatments of Migraine With Triptans in Pregnant Women: Eclampsia/preeclampsia	up to delivery
Secondary	Tubal or ectopic pregnancy	Treatments of Migraine With Triptans in Pregnant Women: Tubal or ectopic pregnancy	up to delivery
Secondary	Major fetal malformations	Treatments of Migraine With Triptans in Pregnant Women: Major fetal malformations	up to delivery