Completed

DUP-SURPASSSURPASS-CVOT Cardiovascular Outcome Trial Prediction in Healthcare Claims Data

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Study Aim

This study observes how tirzepatide and dulaglutide impact the first occurrence of major cardiovascular events in patients with type 2 diabetes and an established cardiovascular disease or elevated cardiovascular risk.

What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Cardiovascular Diseases+4

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 2

Over 40 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 2024
See protocol details

Summary

Principal SponsorBrigham and Women's Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2024

Actual date on which the first participant was enrolled.

This study focuses on understanding the effects of two medications, tirzepatide and dulaglutide, on heart-related events in people with type 2 diabetes and existing heart disease. These heart-related events include heart attacks, strokes, or death from heart-related causes. The study uses data from healthcare insurance claims to mimic a larger trial called SURPASS-CVOT. Although it can't replicate every aspect of the original trial, it aims to give an insight into how these medications might be impacting patients in real-world settings. This research is crucial as it could help improve treatment strategies for individuals with type 2 diabetes who are already dealing with heart problems. Participants in the study are those aged 40 or older, with type 2 diabetes and a history of cardiovascular disease. The study compares the effects of the two medications by analyzing insurance claims data to see which one better prevents major heart-related events. Since this is an observational study, it doesn't involve direct intervention like giving medications to participants. Instead, it uses statistical methods to balance different factors among the study group, aiming to predict the potential outcomes of the SURPASS-CVOT trial before its results are officially released. This approach provides a valuable way to assess the effectiveness of these treatments using existing data.

Official TitlePrediction of the SURPASS-CVOT Cardiovascular Outcome Trial in Healthcare Claims Data
NCT07088718
Principal SponsorBrigham and Women's Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

44671 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

5 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Brigham and Women's Hospital

Boston, United StatesOpen Brigham and Women's Hospital in Google Maps
CompletedOne Study Center