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Trial record 54 of 134 for:    OLMESARTAN

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

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ClinicalTrials.gov Identifier: NCT02516826
Recruitment Status : Unknown
Verified August 2015 by Hyeon-Cheol Gwon, Samsung Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 6, 2015
Last Update Posted : August 6, 2015
Sponsor:
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Coronary Syndrome Drug: Rosuvastatin Drug: Olmesartan Drug: Combination Drug: Placebo of Rosuvastatin Drug: Placebo of Olmesartan Drug: Placebo of Rosuvastatin/Olmesartan(Combination) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Rosuvastatin and Olmesartan on the Progression of Coronary Atherosclerotic Disease by Smart Angioplasty Research Team: SMART-ROAD Trial
Study Start Date : August 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rosuvastatin Arm
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)
Experimental: Olmesartan Arm
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)
Experimental: Combination Arm
Olmesartan/Rosuvastatin(Combination) 20/10mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan 20mg
Drug: Combination
Rosuvastatin/Olmesartan(Combination)

Drug: Placebo of Rosuvastatin
Drug: Placebo of Olmesartan



Primary Outcome Measures :
  1. PAV(nominal change of percent atheroma volume) in the proximal to mid segments of major epicardial coronary arteries [ Time Frame: Over the 48weeks ]
    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)


Secondary Outcome Measures :
  1. TAV (nominal change of total atheroma volume) in the proximal to mid segments of major epicardial coronary arteries [ Time Frame: Over the 48weeks ]
    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)

  2. LAPV (nominal change of percent low attenuation plaque volume) [ Time Frame: Over the 48weeks ]
  3. Nominal change of atheroma volume in 10 mm subsegment with greatest disease severity [ Time Frame: Over the 48weeks ]
  4. Change in insulin resistance [ Time Frame: Over the 48weeks ]
  5. Major adverse cardiac events [ Time Frame: Over the 48weeks ]


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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516826


Contacts
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Contact: Hyeon-Cheol Gwon, PhD 2-3410-3418 ext 82 hcqwon@skku.edu
Contact: Young Bin Song, PhD 2-3410-3419 ext 82 yoingbin.song@gmail.com

Locations
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Korea, Republic of
Cardiac and Vascular Center; Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Hyeon-Cheol Gwon, PhD Samsung Medical Center,Seoul,Korea

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Responsible Party: Hyeon-Cheol Gwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02516826     History of Changes
Other Study ID Numbers: 2015-01-055
First Posted: August 6, 2015    Key Record Dates
Last Update Posted: August 6, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Olmesartan
Olmesartan Medoxomil
Disease Progression
Disease Attributes
Pathologic Processes
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists