Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02516826
Other study ID # 2015-01-055
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received August 4, 2015
Last updated August 4, 2015
Start date August 2015
Est. completion date August 2018

Study information

Verified date August 2015
Source Samsung Medical Center
Contact Hyeon-Cheol Gwon, PhD
Phone 2-3410-3418
Email hcqwon@skku.edu
Is FDA regulated No
Health authority South Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 504
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 70 Years
Eligibility Inclusion Criteria:

1. Subjects must be at 19 years~70 years of age

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:

1. Patients with>=70% luminal stenosis or requiring percutaneous coronary intervention(PCI)

2. Severely calcifiedcoronary artery

3. Patients who have a history of previous PCI or coronary artery bypass grafting surgery.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Rosuvastatin

Olmesartan

Combination
Rosuvastatin/Olmesartan(Combination)
Placebo of Rosuvastatin

Placebo of Olmesartan

Placebo of Rosuvastatin/Olmesartan(Combination)


Locations

Country Name City State
Korea, Republic of Cardiac and Vascular Center; Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary PAV(nominal change of percent atheroma volume) in the proximal to mid segments of major epicardial coronary arteries Left main, LAD proximal to mid (from ostium to a large second diagonal branch), LCX proximal (from ostium to a large first obtuse marginal branch), RCA (from ostium to a distal bifurcation) Over the 48weeks No
Secondary TAV (nominal change of total atheroma volume) in the proximal to mid segments of major epicardial coronary arteries Left main, LAD proximal to mid (from ostium to a large second diagonal branch), LCX proximal (from ostium to a large first obtuse marginal branch), RCA (from ostium to a distal bifurcation) Over the 48weeks No
Secondary LAPV (nominal change of percent low attenuation plaque volume) Over the 48weeks No
Secondary Nominal change of atheroma volume in 10 mm subsegment with greatest disease severity Over the 48weeks No
Secondary Change in insulin resistance Over the 48weeks No
Secondary Major adverse cardiac events Over the 48weeks Yes
See also
  Status Clinical Trial Phase
Completed NCT00982176 - Determinants of Cognitive Impairment After Acute Coronary Syndrome N/A
Recruiting NCT05600088 - Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With NSTEMI or Unstable Angina N/A
Recruiting NCT06273033 - Implementation of Contemporary Coronary CT Angiography in Clinical Practice
Completed NCT03193294 - CORonary MICrovascular Angina (CorMicA) N/A
Recruiting NCT05476991 - Evaluation of Low Dose Colchicine and Ticagrelor in Prevention of Ischemic Stroke in Patients With Stroke Due to Atherosclerosis Phase 3
Completed NCT05140317 - 5 Years Follow up of the SAPIEN 3 Valve From the DIRECTAVI Trial
Recruiting NCT06103357 - Identification of Biomarkers in Subjects With Coronary Syndrome (PLAQUE Study)
Recruiting NCT04325867 - Integrated Distance Management Strategy for Patients With Cardiovascular Diseases in the Context of COVID-19 N/A
Not yet recruiting NCT05300178 - Use of Various Configurations of Different Arterial Grafts in Total Arterial Revascularization
Completed NCT00769574 - Assessment of New Biomarkers in the Management and Triage of Patients With Chest Pain and Suspicion of Non ST Elevation Acute Coronary Syndrome. N/A
Completed NCT00709709 - Medical Evaluation of Scanner in Coronary Syndrome N/A
Completed NCT04881552 - Incidence, Clinical Characteristics and Prognosis of Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Spontaneous Coronary Reperfusion in the Modern Antithrombotic Strategy Area
Recruiting NCT06058182 - RNA as Prognostic Biomarkers in Patients With Acute Coronary Syndrome
Recruiting NCT04864457 - Multi-omics Study of Young Adults Coronary Syndrome Patients
Completed NCT04580017 - Prognostic Accuracy of the HEART Score in Undifferentiated Chest Pain: A Multicenter Validation Study
Recruiting NCT04206683 - Cerebral Oxygenation and Burst Suppression
Completed NCT03312179 - STEMI and Incretins Treatment N/A
Active, not recruiting NCT04936438 - Clinical Cohort Study - INTERCATH
Completed NCT03772613 - The Randomized OPTIMAL-ACT Trial Phase 2
Completed NCT04990791 - WILL lOWer Dose Aspirin be Better With Rivaroxaban in Patients With Chronic Coronary Syndromes? Phase 4