Coronary SyndromePhase 2NCT02516826
The Effect of Rosuvastatin and Olmesartan on the Progression of Coronary Atherosclerotic Disease
A Phase 2 study testing Rosuvastatin, Olmesartan and Combination in people with Coronary Syndrome, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Coronary Syndrome
- What is being tested?
- Rosuvastatin, Olmesartan and Combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 504 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Aug 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Cardiac and Vascular Center; Samsung Medical Center
Seoul, 135-710
About this study
Official title: The Effect of Rosuvastatin and Olmesartan on the Progression of Coronary Atherosclerotic Disease by Smart Angioplasty Research Team: SMART-ROAD Trial
- 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.
- 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.
- 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.
- 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
- Being tested
- Rosuvastatin, Olmesartan, Combination, Placebo of Rosuvastatin, Placebo of Olmesartan
- Medical subject headings
- Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
OlmesartanDrug
CombinationDrug
Rosuvastatin/Olmesartan(Combination)
Placebo of RosuvastatinDrug
Placebo of OlmesartanDrug
Placebo of Rosuvastatin/Olmesartan(Combination)Drug
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin Arm | Experimental | Rosuvastatin 10mg in combination with placebo of Olmesartan 20mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily Receives: 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 Receives: 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 Receives: Drug: Combination; Drug: Placebo of Rosuvastatin; Drug: Placebo of Olmesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Over the 48weeks
Secondary outcomes (5)
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)
Measured: Over the 48weeks
LAPV (nominal change of percent low attenuation plaque volume)
Measured: Over the 48weeks
Nominal change of atheroma volume in 10 mm subsegment with greatest disease severity
Measured: Over the 48weeks
Change in insulin resistance
Measured: Over the 48weeks
Major adverse cardiac events
Measured: Over the 48weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeon-Cheol Gwon, Samsung Medical Center
- Investigators
- Hyeon-Cheol Gwon, PhD, Principal investigator, Samsung Medical Center,Seoul,Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516826
- Sponsor's protocol ID
- 2015-01-055
- Status last verified
- Aug 2015
- First submitted
- 4 Aug 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rosuvastatin and Olmesartan on the Progression of Coronary Atherosclerotic Disease by Smart Angioplasty Research Team: SMART-ROAD Trial
- ClinicalTrials.gov ID
- NCT02516826
- Acronym / sponsor ID
- 2015-01-055
- Conditions
- Coronary Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin Arm | Experimental | Drug: Rosuvastatin, Drug: Placebo of Olmesartan, Drug: Placebo of Rosuvastatin/Olmesartan(Combination)Rosuvastatin 10mg in combination with placebo of Olmesartan 20mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily |
| Olmesartan Arm | Experimental | Drug: Olmesartan, Drug: Placebo of Rosuvastatin, Drug: Placebo of Rosuvastatin/Olmesartan(Combination)Olmesartan 20mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily |
| Combination Arm | Experimental | Drug: Combination, Drug: Placebo of Rosuvastatin, Drug: Placebo of OlmesartanOlmesartan/Rosuvastatin(Combination) 20/10mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan 20mg |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin | Drug | Rosuvastatin Arm |
| Olmesartan | Drug | Olmesartan Arm |
| CombinationRosuvastatin/Olmesartan(Combination) | Drug | 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 |
Primary outcome
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)
5 secondary outcomes
TAV (nominal change of total atheroma volume) in the proximal to mid segments of major epicardial coronary arteries
Time frame: Over the 48weeks
LAPV (nominal change of percent low attenuation plaque volume)
Time frame: Over the 48weeks
Nominal change of atheroma volume in 10 mm subsegment with greatest disease severity
Time frame: Over the 48weeks
Change in insulin resistance
Time frame: Over the 48weeks
Major adverse cardiac events
Time frame: Over the 48weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyeon-Cheol Gwon, PhD principal investigator
Samsung Medical Center,Seoul,Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rosuvastatin, Olmesartan and Combination in people with Coronary Syndrome, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyeon-Cheol Gwon, PhD (2-3410-3418 ext. 82, hcqwon@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAV(nominal change of percent atheroma volume) in the proximal to mid segments of major epicardial coronary arteries (time frame: Over the 48weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.