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A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events

NCT06112418 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7500

Last updated 2026-05-20

No results posted yet for this study

Summary

TRANSFORM is a prospective, randomized, open blinded endpoint (PROBE), event-driven, pragmatic trial in patients who are at increased risk for atherosclerotic cardiovascular (CV) disease but with no known symptomatic CV disease. The trial tests the hypothesis that a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy reduces CV events compared with risk factor-based care.

Conditions

Interventions

DEVICE

The Cleerly CAD Staging System

The Cleerly CAD Staging System is software that utilizes a proprietary algorithm to identify CAD, stage the severity of CAD when present, and generate a prognostic risk score to inform treatment decisions that support CV disease prevention.

Sponsors & Collaborators

  • CPC Clinical Research

    collaborator UNKNOWN

  • Cleerly, Inc.

    lead INDUSTRY

Principal Investigators

  • Deepak Bhatt, MD, MPH · Mt. Sinai Heart

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-06
Primary Completion
2029-03-05
Completion
2029-03-05
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06112418 on ClinicalTrials.gov