CompletedNot Applicable

Prediction of the SURPASS-CVOT Cardiovascular Outcome Trial in Healthcare Claims Data

United States44,671 participantsStarted 2024-10-01

Plain-language summary

Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

FOLLOWING ELIGIBILITY CIRTERIA OF THE SURPASS-CVOT TRIAL Inclusion Criteria: * History of MI, surgical or percutaneous coronary/carotid peripheral artery revascularization * BMI ≥25.0kg/m2 * Type 2 diabetes, diagnosis of coronary/carotid/peripheral artery disease * Age ≥40 years * Male or female sex Exclusion Criteria: * Medullary thyroid carcinoma, MEN syndrome type 2, malignancy * Treatment for diabetic retinopathy//macular edema, pancreatitis, gastric emptying abnormality/bariatric surgery, liver disease, end-stage renal disease or dialysis, pregnancy * Prior use of pramlintide or any GLP-1-RA except tirzepatide or dulaglutide * Cardiovascular event, hospitalization for heart failure * Concurrent use of both drugs i.e. tirzepatide and dulaglutide

What they're measuring

First occurence of MACE (all-cause mortailty, myocardial infarction, or death)

Timeframe: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

Trial details

NCT IDNCT07088718

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-30

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