Last updated: 03/31/2023 06:50:11
A Retrospective Study Assessing the Risk of Cardiovascular and Death Related Events in Adults with Selected Cardiovascular Conditions Treated with Oral Triptan Medications for Migraine.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Ongoing
Ongoing
Trial overview
Official title: Risk of Cardiovascular Outcomes and Mortality among Migraine Patients with Pre-Existing Cardiovascular Conditions who are Treated with Triptans in the United States
Trial description: The purpose of this study is to compare the hazard of cardiovascular (CV) outcomes between participantstreated with triptans versus other anti-migraine therapies (that is [i.e.] opioids or Nonsteroidal anti-inflammatory drug [NSAIDs])
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Time to First Occurrence of Non-fatal Myocardial Infarction [MI] Following the Index Date
Timeframe: Baseline period 1 (12 months [at least 1 diagnosis of migraine within 6 months prior to index date 1]) to Risk Period 2 (time from index date 2 to end of risk period 2)
Time to First Occurrence of Non-fatal Stroke Following the Index Date
Timeframe: Baseline period 1 (12 months [at least 1 diagnosis of migraine within 6 months prior to index date 1]) to Risk Period 2 (time from index date 2 to end of risk period 2)
All-cause Mortality (Number of Participants Reported Death)
Timeframe: Baseline period 1 (12 months [at least 1 diagnosis of migraine within 6 months prior to index date 1) to Risk Period 2 (time from index date 2 to end of risk period 2])
Time to Subsequent Major Adverse Cardiovascular Events (MACE)
Timeframe: Baseline period 1 (12 months [at least 1 diagnosis of migraine within 6 months prior to index date 1) to Risk Period 2 (time from index date 2 to end of risk period 2])
Secondary outcomes:
Treatment Patterns Among Participants who are Treated with Triptans, NSAIDs, or Opioids
Timeframe: From index prescription date to end of the study period (i.e., the earliest of end of clinical activity, end of data availability, or death)
Demographic and clinical characteristics of prescriptions
Timeframe: Baseline and the 12-month period prior to the index date
Interventions:
Drug: Anti-Migraine Treatment
Enrollment:
10000
Observational study model:
Cohort
Primary completion date:
2022-31-03
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Pain
Product
sumatriptan
Collaborators
Not applicable
Study date(s)
September 2021 to March 2022
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
- At least one prescription for oral triptans (i.e., sumatriptan, naratriptan, zolmitriptan, rizatriptan, almotriptan, frovatriptan, and eletriptan), opioids, or NSAIDs between January 1, 2006 and February 1, 2020 (to allow for at least 6 months of follow-up)
- A) Prescriptions will be identified by searching drug names in patients’ medication records (see Appendix A for a complete list of drug names)
- At least one ICD-9-CM/ICD-10-CM code associated with a cluster headache diagnosis (ICD-9-CM: 339.00, 339.01, 339.02; ICD-10-CM: G44.00x, G44.01x, G44.02x)
- Date of death prior to the index date
Inclusion and exclusion criteria
Inclusion criteria:
- At least one prescription for oral triptans (i.e., sumatriptan, naratriptan, zolmitriptan, rizatriptan, almotriptan, frovatriptan, and eletriptan), opioids, or NSAIDs between January 1, 2006 and February 1, 2020 (to allow for at least 6 months of follow-up) A) Prescriptions will be identified by searching drug names in patients’ medication records (see Appendix A for a complete list of drug names) B) The index date of will be identified as the first day on which the prescription meets the inclusion criteria a) Only triptans prescribed as a single anti-migraine treatment will be included. b) All combination therapies of opioids plus a second agent (e.g., hydrocodone-acetaminophen) or NSAIDS plus a second agent (e.g., ibuprofen-acetaminophen), with the exception of opioid plus NSAID combination therapy, will be included
- At least one inpatient or two outpatient The International Classification of Diseases, Ninth Revision, Clinical Modification / The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-9-CM/ICD-10-CM) codes associated with migraine (ICD-9-CM: 346.x; ICD-10-CM: G43.0x, G43.1x-G43.7x, G43.8x-G43.9x) within 6 months prior to the index date A) If the sample size decreases substantially due to the 6-month assessment period for migraine, longer assessment periods up to 12 months will be considered. B) The number of anti-migraine drug prescriptions on the date of the migraine diagnosis will be assessed to determine whether requiring a prescription on the day of a migraine diagnosis can yield sufficient sample size for the analyses. If sample size allows, requiring at least one diagnosis for migraine on the same day as the index date may be considered. C) Other diagnoses on the same day as the anti-migraine drug prescription will also be evaluated to determine whether the medication was indicated specifically for migraine.
- At least 12 months of clinical activity prior to the index date (i.e., baseline)
- At least one ICD-9-CM/ICD-10-CM code associated with a CV condition during baseline (see Appendix B for a complete list of codes and criteria). Baseline CV conditions will include those that were identified as Contraindications or Warnings and Precautions regarding CV diseases and CV risk factors on triptan labels, as operationalized in a previous study (Dodick et al., 2020)44: A) Contraindications specifically listed in triptan labels a) Ischemic heart disease b) Cerebrovascular disease c) Peripheral artery disease d) Uncontrolled hypertension e) Gastrointestinal ischemia B) Warnings and Precautions regarding CV diseases and CV risk factors a) Potentially life-threatening arrhythmias b) Structural heart disease c) Presence of cardiac implants (e.g., coronary grafts) d) Other serious cardiac conditions (e.g., cardiac arrest)
- At least 18 years old as of the index date
Exclusion criteria:
- At least one ICD-9-CM/ICD-10-CM code associated with a cluster headache diagnosis (ICD-9-CM: 339.00, 339.01, 339.02; ICD-10-CM: G44.00x, G44.01x, G44.02x)
- Date of death prior to the index date
Trial location(s)
No location data available.
Study documents
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Ongoing
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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