Emulation of the REWIND Cardiovascular Outcomes Trial in Healthcare Claims Data.

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07417631
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dulaglutide — DRUG
    Initiation of dulaglutide dispensing claim is used as the exposure.
  • Sitagliptin — DRUG
    Initiation of sitagliptin dispensing claim is used as the reference.

Study Details

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.

Key Dates

Start date
Feb 3, 2026
Status verified
Feb 2026
Primary completion
Jun 15, 2026
Completion
Jun 15, 2026

Study Design

Enrollment
300,000 participants (estimated)

Arms

  • Arm: Initiation of dulaglutide
    Exposure group
  • Arm: Initiation of sitagliptin
    Reference group

Primary Outcome Measure

Time to first occurrence of myocardial infarction, stroke, or all-cause mortality [ Time Frame: From cohort entry through first occurrence of outcome, disenrollment, end of the study period, treatment discontinuation +45-day grace/risk window, treatment switch between arms, nursing home admission, start of another GLP-1 RA, assessed up to 1 year. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02120-

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