High-intensity Statin and Ezetimibe Therapy for Asymptomatic Patients With Positive Coronary Calcium

NCT05845424 | Recruiting Phase 4 DMC

• 1 other identifier: DECISION-CALCIUM
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare safety and efficacy between the aggressive treatment with combination of high-intensity statin and ezetimibe and the current standard lipid lowering treatment in asymptomatic patients with presence of coronary calcification.

Conditions

Coronary Artery Calcification; Metabolic Syndrome; Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events

  a composite of death from any causes, myocardial infarction, stroke, unplanned coronary revascularization, or other arterial revascularization procedure

  up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)

Secondary Outcomes (15)

• All-cause death

  up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)

• Cardiovascular death

  up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)

• Stroke

  up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)

• Unplanned coronary revascularization

  up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)

• Arterial revascularization procedure

  up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)

Study Arms (2)

Aggressive treatment arm

EXPERIMENTAL

In this group, high-intensity statin (rosuvastatin 20mg) combined with ezetimibe 10 mg will be prescribed regardless of patients' age, concomitant diabetes mellitus, or ASCVD risk.

Drug: High intensity statin plus ezetimibe therapy

Standard treatment arm

ACTIVE COMPARATOR

In this group, lipid lowering therapy will be followed according to the current guideline recommendation. A moderate-intensity statin (rosuvastatin 5 mg) will be prescribed for patients over 75 years of age or with diabetes mellitus. For non-diabetic patients aged 40-75 years, the use of statins will be determined by calculating the ASCVD risk score. (ASCVD risk \<7.5%: no statin use, ≥7.5 - \<20%: moderate-intensity statin \[rosuvastatin 5mg\], ≥ 20%: high-intensity statin \[rosuvastatin 20mg\])

Drug: Guideline directed statin therapy

Interventions

Guideline directed statin therapy DRUG

At least moderate intensity statin, recommended by the current guideline based on the ASCVD risk

Standard treatment arm

High intensity statin plus ezetimibe therapy DRUG

Rosuvastatin 20 mg + Ezetimibe 10 mg

Aggressive treatment arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 40 years of age.
• Asymptomatic patients with presence of coronary calcification (Agatston Score ≥ 100)
• low-density lipoproteins cholesterol (LDL-C) \<190 mg/dL

You may not qualify if:

• Objective evidence of at least moderate inducible ischemia requiring revascularization treatment
• History of cerebrovascular disease
• History of coronary or peripheral arterial revascularization
• Active liver disease or persistent unexplained serum transaminase elevations more than 2 times the upper limit of normal range
• History of any adverse drug reaction requiring discontinuation of statin (e, g. rhabdomyolysis)
• Allergy or sensitivity to any statin or ezetimibe
• Concurrent treatment with cyclosporine or a condition likely to result in organ transplantation and the need for cyclosporine
• Pregnancy or breast feeding
• Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
• Unwillingness or inability to comply with the procedures described in this protocol.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

SamsungMedicalCenter

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Dyslipidemias

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders

Study Officials

• Seung-Hyuk Choi

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung-Hyuk Choi, MD

CONTACT

82-2-3410-3419; sh1214.choi@samsung.com

Ki Hong Choi, MD

CONTACT

82-2-3410-6653; cardiokh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A prospective, open label, multicenter randomized controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: standard treatment vs. aggressive treatment

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: July 3, 2023
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)