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The Effect of Rosuvastatin and Olmesartan on the Progression of Coronary Atherosclerotic Disease

NCT02516826 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2015-08-06

No results posted yet for this study

Summary

1. Stains have demonstrated consistent benefits to reduce cardiovascular events in several primary and secondary prevention trials. The suppression of plaque progression or regression may be a part of mechanism of clinical benefit. The intravascular ultrasound studies demonstrated that intensive statin therapy can regress or inhibit the progression of coronary atherosclerosis.
2. Unregulated renin-angiotensin system is important in the pathogenesis of cardiovascular disease. Angiotensin receptor antagonists (ARB) have been reported to improve clinical outcomes in patients with heart failure, left ventricular dysfunction, myocardial infarction, and high-risk patients. Several small studies showed that ARBs were effective to inhibit the progression of coronary atherosclerosis by intravascular ultrasound examination.
3. The combined therapy with statins and ARBs may be additive or synergistic effects on the atherosclerosis regression as well as to improve endothelial dysfunction and insulin resistance in addition to lowering cholesterol levels and blood pressure when compared with either monotherapy in patients.
4. Serial computed tomography angiography (CTA) can be utilized to assess the effect of treatment on coronary plaque morphology. In addition to the assessment of luminal stenosis, CTA also allows characterization of plaque morphology.

Conditions

  • Coronary Syndrome

Interventions

DRUG

Rosuvastatin

DRUG

Olmesartan

DRUG

Combination

Rosuvastatin/Olmesartan(Combination)

DRUG

Placebo of Rosuvastatin

DRUG

Placebo of Olmesartan

DRUG

Placebo of Rosuvastatin/Olmesartan(Combination)

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Hyeon-Cheol Gwon, PhD · Samsung Medical Center,Seoul,Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • South Korea

Study Locations

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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 NCT02516826 on ClinicalTrials.gov