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

Coronary Syndrome Clinical Trial

Official title:

The Effect of Rosuvastatin and Olmesartan on the Progression of Coronary Atherosclerotic Disease by Smart Angioplasty Research Team: SMART-ROAD Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02516826
• Other study ID #: 2015-01-055
• 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

• Coronary Syndrome

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