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Coronary Artery DiseasePhase 4STABLENCT00997880

Statin and Atheroma Vulnerability Evaluation

A Phase 4 study testing Rosuvastatin calcium 40mg and Rosuvastatin calcium10mg in people with Coronary Artery Disease, run by Seung-Jung Park at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the effect of statin therapy on the modification of atherosclerotic plaque composition and vulnerability in non-intervened coronary arteries with mild to moderate stenosis using VH-IVUS and OCT. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Rosuvastatin calcium 40mg and Rosuvastatin calcium10mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
1 siteSouth Korea
Study dates
Apr 2010to Dec 2014
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female at least 18 years of age inclusive.
  • Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia who will undergo either planned coronary angiography, or percutaneous coronary intervention
  • Non-culprit de novo lesion in a native coronary artery with at least one deferred coronary lesion with 1) visually-estimated angiographic % diameter stenosis 20-50% or 2) % diameter stenosis >50% without any evidence of inducible ischemia (FFR≥0.8 or negative perfusion on thiallium scan or negative treadmill test). Index lesion should have at least 1 fibroatheroma or TCFA.
  • The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site

Who cannot join

  • Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy) or planned major non-cardiac surgery within the study period
  • Stroke or resuscitated sudden death in the past 6 months
  • Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible)
  • Untreated hyperthyroidism, or hypothyroidism with TSH levels more than 1.5 times upper limit of normal
  • A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer
  • Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study
Show all 17Show fewer
  • Evidence of congestive heart failure, or left ventricular ejection fraction < 40%
  • Significant renal disease manifested by serum creatinine > 2.0mg/dL, or creatinine clearance of < 40 ml/min (by Cockcroft-Gault method)
  • Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal)
  • History of myopathy or elevated creatine kinase (CK) > 3 times upper normal limit at screening
  • History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s)
  • Unwillingness or inability to comply with the procedures described in this protocol
  • History of any arterial bypass or angioplastic intervention involving the target vessel
  • The luminal narrowing in the target vessel or in the left main coronary artery >50% by visual inspection of angiogram
  • Luminal diameter of the target vessel < 2.5mm by visual inspection of coronary angiogram
  • Presence of thrombus or complex plaque morphology in the target vessel that suggests a high likelihood of distal embolism
  • Severe tortuosity of the target vessel or any other anatomical reasons that the investigator deems inappropriate for IVUS procedures

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, Republic of Korea, 138-736

Other trials in South Korea

About this study

Official title: Effect of High-Dose and Low-Dose Statin for Coronary Plaque Modification

The purpose of this study is to evaluate the effect of statin therapy on the modification of atherosclerotic plaque composition and vulnerability in non-intervened coronary arteries with mild to moderate stenosis using VH-IVUS and OCT.

Read the detailed description

At present, there is no proven drug or modality to stabilize the vulnerable plaques. A number of drugs that are beneficial for patients with coronary disease may act in part by improving the stability of plaques that are vulnerable for future rupture. Especially, Lipid-lowering therapy, particularly with statins, can stabilize vulnerable plaques or those that have already ruptured by improving endothelial function and reducing thrombogenicity, platelet aggregation, and possibly inflammation. As the atherosclerotic disease has progressed, there is an increase of the atherosclerotic plaque amounts. However, the changes of specific plaque compositions within the atherosclerotic lesions have not been sufficiently evaluated. Previous pathologic findings reported that there was a significant relation between the plaque size and necrotic core size.Conventional grey-scale intravascular ultrasound (IVUS) has significant limitations in accurately assessing atheromatous plaque composition. These limitations have been partially addressed by radiofrequency signal processing with spectral analysis of the back-scattered ultrasound signals. Using this technology, Virtual Histology (VH) IVUS is capable of characterizing plaque as calcified (white), fibrotic (dark-green), fibrofatty (yellow-green), and necrotic core (red). In addition, optical coherence tomography (OCT) is a light-based imaging modality that can be used in biological systems to study tissues in vivo with near-histologic, ultrahigh resolution. The rationale for intravascular application of OCT is its potential for in vivo visualizations of the coronary artery microstructure. This unique image resolution of OCT offers the potential to detect key features of vulnerable plaque in vivo. Beyond the inherent limitations of angioscopy and intravascular ultrasound, OCT might offer a much higher sensitivity in the detection of necrotic/lipid cores within coronary atheromas. Therefore, plaque characterization using VH-IVUS and OCT may provide detailed morphologic insights of plaque vulnerability.

We hypothesized that statin would provide benefits to stabilize coronary plaque composition by LDL-reduction and/or a pleiotropic effect. We also hypothesized that high-dose statin would be more beneficial in reducing the vulnerable plaque and stabilizing the vulnerable plaque composition than low-dose statin.

Being tested
Rosuvastatin calcium 40mg, Rosuvastatin calcium10mg
Keywords
rosuvastatin
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rosuvastatin calcium 40mgDrug

    Also called CRESTOR® 40mg

    Rosuvastatin calcium 40mg

  • Rosuvastatin calcium10mgDrug

    Also called CRESTOR® 10mg

    Rosuvastatin 10mg

Study groups in NCT00997880
Study groupRoleWhat they receive
Rosuvastatin calcium 40mgExperimentalhigh-dose (40mg rosuvastatin)
Receives: Drug: Rosuvastatin calcium 40mg
Rosuvastatin calcium10mgActive comparatorlow-dose statin (10mg rosuvastatin)
Receives: Drug: Rosuvastatin calcium10mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent compositional change of coronary plaque in the entire pullback length Percent compositional c Percent hange of coronary plaque in the entire pullback length of "target segment" (within both proximal and distal fiduciary sites)

    Measured: 12months

Secondary outcomes (4)

  1. VH-IVUS parameters

    Measured: 12months

  2. Conventional IVUS parameters

    Measured: 12months

  3. OCT Sub-study parameters

    Measured: 12months

  4. Serum biomarkers

    Measured: 12months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2009 (estimated)
  2. Study startApr 2010
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00997880
Sponsor's protocol ID
2008-0361
Acronym
STABLE
Status last verified
Dec 2014
First submitted
18 Oct 2009
Last updated
25 Dec 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Kwon O, Kang SJ, Kang SH, Lee PH, Yun SC, Ahn JM, Park DW, Lee SW, Kim YH, Lee CW, Han KH, Park SW, Park SJ. Relationship Between Serum Inflammatory Marker Levels and the Dynamic Changes in Coronary Plaque Characteristics After Statin Therapy. Circ Cardiovasc Imaging. 2017 Jul;10(7):e005934. doi: 10.1161/CIRCIMAGING.116.005934.

    PubMed 28679524

  • Park SJ, Kang SJ, Ahn JM, Chang M, Yun SC, Roh JH, Lee PH, Park HW, Yoon SH, Park DW, Lee SW, Kim YH, Lee CW, Mintz GS, Han KH, Park SW. Effect of Statin Treatment on Modifying Plaque Composition: A Double-Blind, Randomized Study. J Am Coll Cardiol. 2016 Apr 19;67(15):1772-1783. doi: 10.1016/j.jacc.2016.02.014.

    PubMed 27081016

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rosuvastatin calcium 40mg and Rosuvastatin calcium10mg in people with Coronary Artery Disease, run by Seung-Jung Park 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 4 inclusion and 17 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: finished, as of the sponsor's last update on 25 Dec 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent compositional change of coronary plaque in the entire pullback length Percent compositional c Percent hange of coronary plaque in the entire pullback length of "target segment" (within both proximal and distal fiduciary sites) (time frame: 12months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00997880, which also lists 2 linked publications.

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 25 Dec 2014.

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Statin and Atheroma Vulnerability Evaluation | AzTrials