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

NCT02516826 | Unknown Phase 2

• 1 other identifier: 2015-01-055
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• TAV (nominal change of total atheroma volume) in the proximal to mid segments of major epicardial coronary arteries

  Over the 48weeks

• LAPV (nominal change of percent low attenuation plaque volume)

  Over the 48weeks

• Nominal change of atheroma volume in 10 mm subsegment with greatest disease severity

  Over the 48weeks

• Change in insulin resistance

  Over the 48weeks

• Major adverse cardiac events

  Over the 48weeks

Study Arms (3)

Rosuvastatin Arm

EXPERIMENTAL

Rosuvastatin 10mg in combination with placebo of Olmesartan 20mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily

Drug: Rosuvastatin; Drug: Placebo of Olmesartan; Drug: Placebo of Rosuvastatin/Olmesartan(Combination)

Olmesartan Arm

EXPERIMENTAL

Olmesartan 20mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily

Drug: Olmesartan; Drug: Placebo of Rosuvastatin; Drug: Placebo of Rosuvastatin/Olmesartan(Combination)

Combination Arm

EXPERIMENTAL

Olmesartan/Rosuvastatin(Combination) 20/10mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan 20mg

Drug: Combination; Drug: Placebo of Rosuvastatin; Drug: Placebo of Olmesartan

Interventions

Rosuvastatin DRUG

Rosuvastatin Arm

Olmesartan DRUG

Olmesartan Arm

Combination DRUG

Rosuvastatin/Olmesartan(Combination)

Combination Arm

Placebo of Rosuvastatin DRUG

Combination Arm; Olmesartan Arm

Placebo of Olmesartan DRUG

Combination Arm; Rosuvastatin Arm

Placebo of Rosuvastatin/Olmesartan(Combination) DRUG

Olmesartan Arm; Rosuvastatin Arm

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be at 19 years\~70 years of age
• Patients undergoing coronary CTA with coronary artery stenosis 30\~70%
• Informed consent
• Appropriate CT resolution enough to measure of plaque volume
• Patients who are stain and renin-angiotensin system blocker naïve at least for 1 year

You may not qualify if:

• Patients with\>=70% luminal stenosis or requiring percutaneous coronary intervention(PCI)
• Severely calcifiedcoronary artery
• Patients who have a history of previous PCI or coronary artery bypass grafting surgery.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Cardiac and Vascular Center; Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Angina, Unstable

Interventions

Rosuvastatin Calcium; olmesartan

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hyeon-Cheol Gwon, PhD

  Samsung Medical Center,Seoul,Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyeon-Cheol Gwon, PhD

CONTACT

2-3410-3418; hcqwon@skku.edu

Young Bin Song, PhD

CONTACT

2-3410-3419; yoingbin.song@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 6, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 6, 2015

Record last verified: 2015-08

Locations

KR (1)