INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07417618
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Dulaglutide — DRUG
    Initiation of dulaglutide dispensing claim is used as the exposure.
  • Semaglutide — DRUG
    Initiation of semaglutide dispensing claim is used as the exposure.
  • Tirzepatide — DRUG
    Initiation of tirzepatide 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
Jan 27, 2026
Status verified
Feb 2026
Primary completion
May 22, 2026
Completion
May 22, 2026

Study Design

Enrollment
60,000 participants (estimated)

Arms

  • Arm: Initiation of dulaglutide, semaglutide or tirzepatide
    Exposure group.
  • Arm: Initiation of sitagliptin
    Reference group.

Primary Outcome Measure

Composite of myocardial infarction, stroke, or all-cause mortality (with ASCVD) [ Time Frame: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02120-

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By research site
Brigham and Women's Hospital· Boston, MA

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