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.
Cardiovascular disease (CVD) persists as the leading cause of morbidity and mortality worldwide at high societal cost. The current primary CVD prevention strategy relies upon risk stratification using population health markers such as age, sex, diabetes, hypertension, dyslipidemia and tobacco use, with preventive therapy intensified in higher risk strata. Since these risk factors are indirect surrogate markers of the underlying disease, atherosclerosis, this strategy leads to treatment of individuals with risk factors who do not have atherosclerosis and failure to treat those with significant atherosclerosis who lack risk factors. The current strategy also cannot determine which individuals are inadequately treated despite effective risk factor management (residual risk). With the current approach, the CV death rate is trending upward in the US despite evidence that screening asymptomatic patients reduces CV events and the widespread availability of effective preventive therapies. This randomized, controlled, pragmatic trial is designed to address the unmet need for better strategies to identify asymptomatic individuals at increased risk for CV events due to atherosclerosis and to personalize their treatment based on CV risk estimates using coronary artery disease (CAD) visualization and quantification. This study enrolls patients without known symptoms of ASCVD but who are at increased risk for ASCVD due to their age and having diabetes, prediabetes or metabolic syndrome and tests the hypothesis that a CAD Staging System-based care strategy reduces CV events compared with risk factor-based care. The Cleerly CAD Staging System incorporates imaging-based evaluation for coronary atherosclerosis, algorithm-supported pharmacotherapy and personalized education about their CAD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
7,500
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.
Chandler Clinical Trials
Chandler, Arizona, United States
RECRUITINGScottsdale Clinical Trials
Scottsdale, Arizona, United States
RECRUITINGSun City Research
Sun City, Arizona, United States
RECRUITINGNoble Clinical Research
Tucson, Arizona, United States
The primary objective is to compare Cleerly stage-based care with risk factor-based care on the risk of CV events.
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.
Time frame: Through study completion- an average of 3.5 years
The secondary objective is to compare Cleerly CAD stage-based care with risk factor-based care on other clinical events of CV and renal morbidity and mortality.
The secondary endpoints are time from randomization to first occurence of an event in the primary efficacy endpoint.
Time frame: Through study completion- an average of 3.5 years
The secondary objective is to compare Cleerly CAD stage-based care with risk factor-based care on other clinical events of CV and renal morbidity and mortality.
The secondary endpoints are total occurences after randomization of the primary efficacy endpoing, kidney failure, sustained estimated glomerular filtration rate (eGFR) decrease \>40% from baseline, and death from renal causes.
Time frame: Through study completion- an average of 3.5 years
The secondary objective is to compare Cleerly CAD stage-based care with risk factor-based care on other clinical events of CV and renal morbidity and mortality.
The secondary endpoints are first and total occurrences after randomization of coronary death, MI, and urgent coronary revascularization.
Time frame: Through study completion- an average of 3.5 years
The secondary objective is to compare Cleerly CAD stage-based care with risk factor-based care on other clinical events of CV and renal morbidity and mortality.
The secondary endpoints are time from randomization to first occurrence of MI or ischemic stroke.
Time frame: Through study completion- an average of 3.5 years
The secondary objective is to compare Cleerly CAD stage-based care with risk factor-based care on other clinical events of CV and renal morbidity and mortality.
The secondary endpoints are time from randomization to all-cause death.
Time frame: Through study completion- an average of 3.5 years
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Cardiovascular Research Foundation of Southern California
Beverly Hills, California, United States
RECRUITINGAmicis Research: Beverly Hills
Beverly Hills, California, United States
RECRUITINGValiance Clinical Research - Canoga Park
Canoga Park, California, United States
RECRUITINGCardiovascular Institute of San Diego
Chula Vista, California, United States
RECRUITINGAmicis Research: Granada Hills
Granada Hills, California, United States
RECRUITINGValiance Clinical Research: Huntington Park
Huntington Park, California, United States
RECRUITING...and 115 more locations