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NCT06112418 · ClinicalTrials.gov registry record · NA

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

A NA study of Diabetes Mellitus, Type 2 and PreDiabetes, sponsored by Cleerly.

Recruiting
Registry status
NA
Development phase
7,500
Enrollment target
20
Study locations

NCT06112418: Recruiting NA study of Diabetes Mellitus, Type 2 and PreDiabetes, sponsored by Cleerly.

NCT06112418 is a NA study of Diabetes Mellitus, Type 2 and PreDiabetes that is actively recruiting participants, run by Cleerly. The registered enrollment target is 7,500 participants, above the 4,464-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (68% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06112418, a NA study of Diabetes Mellitus, Type 2 and PreDiabetes, is actively recruiting participants, sponsored by Cleerly.

RECRUITING
Registry status
NA
Development phase
7,500 participants
Enrollment target
20
Study locations

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.

Primary Outcome

The primary endpoint is total (first and subsequent) events for the composite endpoint of CV death, myocardial infarction (MI), ischemic stroke, acute limb ischemia, clinically driven arterial revascularization, and hospitalization or urgent visit for heart failure.

Interventions

  • DEVICE The Cleerly CAD Staging System

Study Locations (20)

California

  • Cardiovascular Research Foundation of Southern California - Beverly Hills
  • Amicis Research: Beverly Hills - Beverly Hills
  • Valiance Clinical Research - Canoga Park - Canoga Park
  • Cardiovascular Institute of San Diego - Chula Vista
  • Amicis Research: Granada Hills - Granada Hills
  • Valiance Clinical Research: Huntington Park - Huntington Park
  • HALO Diagnostics - Indian Wells
  • Scripps Health - La Jolla
  • Chemidox Clinical Trials - Lancaster
  • Long Beach Research Institute - Long Beach
  • Ace Research Institute - Monterey Park - Monterey Park
  • Amicis Research: Newhall - Newhall
  • Ace Research Institute: Northridge - Northridge
  • Amicis Research: Northridge - Northridge
  • Ace Research Institute: Northridge #2 - Northridge
  • Northridge Clinical Trials - Northridge

Arizona

  • Chandler Clinical Trials - Chandler
  • Scottsdale Clinical Trials - Scottsdale
  • Sun City Research - Sun City
  • Noble Clinical Research - Tucson

Trial Details

FieldValue
Enrollment Target 7,500 participants
Start Date 2024-03-06
Est. Completion 2029-03-05
Phase NA
Cleerly

2 total trials

What NCT06112418 shows while recruiting

NCT06112418 is an interventional study that assigns participants to a tested intervention. Its 7,500 participants enrollment target places it among the larger protocols in the corpus, above the 4,464-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (68% higher).

The record links to 3 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 1 intervention - of which The Cleerly CAD Staging System is the first listed.

NCT06112418 names 20 study sites across 2 states, led by California, Arizona.

Frequently Asked Questions

What is clinical trial NCT06112418 about?

NCT06112418 is a clinical study titled "A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events". 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 (...

What is the current status of trial NCT06112418?

This trial is currently recruiting. It is a NA study. The enrollment target is 7,500 participants. The study started on 2024-03-06. Estimated completion is 2029-03-05.

What conditions does trial NCT06112418 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, PreDiabetes, Metabolic Syndrome.

What interventions are being tested in trial NCT06112418?

The interventions under investigation include: The Cleerly CAD Staging System (DEVICE).

Who is sponsoring clinical trial NCT06112418?

This trial is sponsored by Cleerly, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06112418 being conducted?

This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Diabetes Mellitus, Type 2

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06112418's enrollment target sits among peer trials

7,500 15th of 348 higher than 334 of 348 other Diabetes Mellitus, Type 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06112418, the US trial registry maintained by the National Library of Medicine. NCT06112418 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.