A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorCleerly, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provided electronic or written informed consent
Men > 55, women > 65 years of age
Body mass index ≥ 27 kg/m2 or abnormal waist circumference defined as ≥ 80 cm (31.5 inches) for women, ≥ 94 cm (37 inches) for men; for South and East Asian men (e.g., Asian Indian, Chinese, Japanese) ≥ 90 cm (35.4 inches)
Fasting triglycerides ≥ 150 mg/dL (1.7 mmol/L) or treated hypertriglyceridemia
Disqualifiers
History of symptomatic CVD defined as prior MI, exertional or unstable angina, ischemic stroke, claudication, arterial revascularization for atherosclerosis or other CVD being actively managed by a cardiologist, e.g. atrial fibrillation, heart failure
Planned arterial revascularization
eGFR < 60 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) or Modification of Diet in Renal Disease (MDRD) equation (www.kidney.org/professionals/kdoqi/gfr_calculator)
Allergy to iodinated contrast or history of contrast-induced nephropathy (including adverse reaction to contrast at screening CCTA) or screening laboratory values consistent with untreated hyperthyroidism. Participants with elevated thyroid-stimulating hormone (TSH) may be enrolled but should be referred to their physician for evaluation for treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
The Cleerly CAD Staging System
DeviceThe 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.
Treatment groups
7,500 Participants
are divided into 2 treatment groupsGroup A: Risk Factor-Based CareNo intervention 0 interventions
Group B: Cleerly Stage-Based CareExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsOther outcomes
1
The safety objective is to assess harm with the 2 prevention strategies
The safety endpoints are Adverse events (AE) leading to discontinuation of study-recommended medication (DAE), serious AE (SAE), adverse device effect (ADE).
Time frame
Through study completion- an average of 3.5 years2
The safety objective is to assess harm with the 2 prevention strategies
The safety endpoints are 20-item Short Form survey (SF-20).
Time frame
Through study completion- an average of 3.5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cleerly, Inc.
Lead sponsor
CPC Clinical Research
Collaborator
Source ClinicalTrials.gov