Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-26 @ 5:08 AM
Study NCT ID:
NCT05854992
Status:
COMPLETED
Last Update Posted:
2024-12-02
First Post:
2023-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatments of Migraine with Triptans in Individuals with Elevated Cardiovascular Risk and in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014363', 'term': 'Tryptamines'}], 'ancestors': [{'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68419}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2023-05-03', 'studyFirstSubmitQcDate': '2023-05-10', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiovascular events (MACE)', 'timeFrame': '60 days of starting treatment', 'description': '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'}, {'measure': 'Full term birth', 'timeFrame': '39 0/7 weeks of gestation through 40 6/7 weeks of gestation', 'description': 'Treatments of Migraine With Triptans in Pregnant Women: number of pregnant women to have a full term birth'}], 'secondaryOutcomes': [{'measure': 'all-cause death', 'timeFrame': '60 days of starting treatment', 'description': 'Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: all-cause death'}, {'measure': 'Nonfatal myocardial infarction', 'timeFrame': '60 days of starting treatment', 'description': 'Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: nonfatal myocardial infarction'}, {'measure': 'Nonfatal stroke', 'timeFrame': '60 days of starting treatment', 'description': 'Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: nonfatal stroke'}, {'measure': 'Heart failure', 'timeFrame': '60 days of starting treatment', 'description': 'Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: Heart failure'}, {'measure': 'Transient cerebral ischemia', 'timeFrame': '60 days of starting treatment', 'description': 'Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: transient cerebral ischemia'}, {'measure': 'Revascularization', 'timeFrame': '60 days of starting treatment', 'description': 'Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: revascularization'}, {'measure': 'Pre-term delivery', 'timeFrame': '37 0/7 weeks of gestation through 38 6/7 weeks of gestation', 'description': 'Treatments of Migraine With Triptans in Pregnant Women: Pre-term delivery'}, {'measure': 'Cesarean section delivery', 'timeFrame': 'up to delivery', 'description': 'Treatments of Migraine With Triptans in Pregnant Women: cesarean section delivery'}, {'measure': 'Spontaneous abortions/miscarriage', 'timeFrame': 'up to delivery', 'description': 'Treatments of Migraine With Triptans in Pregnant Women: Spontaneous abortions/miscarriage'}, {'measure': 'Fetal death/stillbirth', 'timeFrame': 'up to delivery', 'description': 'Treatments of Migraine With Triptans in Pregnant Women: Fetal death/stillbirth'}, {'measure': 'Intra-uterine growth restriction', 'timeFrame': 'up to delivery', 'description': 'Treatments of Migraine With Triptans in Pregnant Women: Intra-uterine growth restriction'}, {'measure': 'Eclampsia/preeclampsia', 'timeFrame': 'up to delivery', 'description': 'Treatments of Migraine With Triptans in Pregnant Women: Eclampsia/preeclampsia'}, {'measure': 'Tubal or ectopic pregnancy', 'timeFrame': 'up to delivery', 'description': 'Treatments of Migraine With Triptans in Pregnant Women: Tubal or ectopic pregnancy'}, {'measure': 'Major fetal malformations', 'timeFrame': 'up to delivery', 'description': 'Treatments of Migraine With Triptans in Pregnant Women: Major fetal malformations'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine', 'Cardiovascular Diseases', 'Pregnancy']}, 'referencesModule': {'references': [{'pmid': '40719668', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '39207344', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are evaluating the safety of triptan treatment of migraine in individuals with elevated cardiovascular risk and in pregnant women.', 'detailedDescription': '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.\n\nTriptans, 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.\n\nTherefore, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible patients were identified through Mayo Clinic electronic health records.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk:\n\nInclusion:\n\n* Aged \\>=18 years\n* At least 1 year history of migraine with or without aura\n* 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;\n* At least 1 year of prior triptan treatment or no previous triptan treatment.\n\nExclusion:\n\n• Prescription of ergot alkaloids or dihydroergotamine within 60 days before or after starting treatment\n\nTreatments of Migraine With Triptans in Pregnant Women\n\nInclusion:\n\n* Aged \\>=18 years\n* Pregnant woman\n* Diagnosis of episodic or chronic migraine with or without aura before pregnancy\n\nExclusion:\n\n• Prescription of ergot alkaloids or dihydroergotamine \\<= 60 days before pregnancy or during pregnancy'}, 'identificationModule': {'nctId': 'NCT05854992', 'briefTitle': 'Treatments of Migraine with Triptans in Individuals with Elevated Cardiovascular Risk and in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Treatments of Migraine with Triptans in Individuals with Elevated Cardiovascular Risk and in Pregnant Women', 'orgStudyIdInfo': {'id': '22-005920'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.', 'interventionNames': ['Drug: Acute migraine treatment with any prescribed triptans']}, {'label': 'Cardiovascular Risk Control Group Treated with No Triptans', 'description': 'Subjects with who did not received Triptans as part of clinical care.', 'interventionNames': ['Drug: Standard of care management of acute migraine without triptans']}, {'label': 'Pregnant Women Group Treated with Triptans', 'description': 'Subjects diagnosed with migraine that received Triptans as part of clinical care during pregnancy.', 'interventionNames': ['Drug: Acute migraine treatment with any prescribed triptans']}, {'label': 'Pregnant Women Control Group Treated with No Triptans', 'description': 'Subjects that did not receive Triptans as part of clinical care during pregnancy.', 'interventionNames': ['Drug: Standard of care management of acute migraine without triptans']}], 'interventions': [{'name': 'Acute migraine treatment with any prescribed triptans', 'type': 'DRUG', 'otherNames': ['Triptans'], 'description': 'Sumatriptan, treximet (sumatriptan/naproxen combination), zolmitriptan, naratriptan, rizatriptan, almotriptan, eletriptan, and frovatriptan. No restriction on dose, frequency, duration, or delivery routes.', 'armGroupLabels': ['Cardiovascular Risk Group Treated with Triptans', 'Pregnant Women Group Treated with Triptans']}, {'name': 'Standard of care management of acute migraine without triptans', 'type': 'DRUG', 'otherNames': ['No triptans'], 'description': 'Any standard of care management without triptans', 'armGroupLabels': ['Cardiovascular Risk Control Group Treated with No Triptans', 'Pregnant Women Control Group Treated with No Triptans']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Minnesota', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Mohammad Murad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'M. Hassan Murad, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}