Clinical trial NCT02516826: The Effect of Rosuvastatin and Olmesartan on the Progression of Coronary Atherosclerotic Disease
Official title: The Effect of Rosuvastatin and Olmesartan on the Progression of Coronary Atherosclerotic Disease by Smart Angioplasty Research Team: SMART-ROAD Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronary Syndrome
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 504
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: PAV(nominal change of percent atheroma volume) in the proximal to mid segments of major epicardial coronary arteries
timeFrame: Over the 48weeks
Secondary outcomes:
measure: TAV (nominal change of total atheroma volume) in the proximal to mid segments of major epicardial coronary arteries
timeFrame: Over the 48weeks
measure: LAPV (nominal change of percent low attenuation plaque volume)
timeFrame: Over the 48weeks
measure: Nominal change of atheroma volume in 10 mm subsegment with greatest disease severity
timeFrame: Over the 48weeks
measure: Change in insulin resistance
timeFrame: Over the 48weeks
measure: Major adverse cardiac events
timeFrame: Over the 48weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Cardiac and Vascular Center; Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center,Seoul,Korea
name: Hyeon-Cheol Gwon, PhD
role: PRINCIPAL_INVESTIGATOR
References: