The Effect of Rosuvastatin and Olmesartan on the Progression of Coronary Atherosclerotic Disease
NCT ID: NCT02516826
Last Updated: 2015-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
504 participants
INTERVENTIONAL
2015-08-31
2018-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rosuvastatin Arm
Rosuvastatin 10mg in combination with placebo of Olmesartan 20mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily
Rosuvastatin
Placebo of Olmesartan
Placebo of Rosuvastatin/Olmesartan(Combination)
Olmesartan Arm
Olmesartan 20mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily
Olmesartan
Placebo of Rosuvastatin
Placebo of Rosuvastatin/Olmesartan(Combination)
Combination Arm
Olmesartan/Rosuvastatin(Combination) 20/10mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan 20mg
Combination
Rosuvastatin/Olmesartan(Combination)
Placebo of Rosuvastatin
Placebo of Olmesartan
Interventions
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Rosuvastatin
Olmesartan
Combination
Rosuvastatin/Olmesartan(Combination)
Placebo of Rosuvastatin
Placebo of Olmesartan
Placebo of Rosuvastatin/Olmesartan(Combination)
Eligibility Criteria
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Inclusion Criteria
2. Patients undergoing coronary CTA with coronary artery stenosis 30\~70%
3. Informed consent
4. Appropriate CT resolution enough to measure of plaque volume
5. Patients who are stain and renin-angiotensin system blocker naïve at least for 1 year
Exclusion Criteria
2. Severely calcifiedcoronary artery
3. Patients who have a history of previous PCI or coronary artery bypass grafting surgery.
19 Years
70 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Hyeon-Cheol Gwon
Professor
Principal Investigators
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Hyeon-Cheol Gwon, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center,Seoul,Korea
Locations
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Cardiac and Vascular Center; Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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2015-01-055
Identifier Type: -
Identifier Source: org_study_id
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