NCT00997880

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 25, 2014

Status Verified

December 1, 2014

Enrollment Period

4.7 years

First QC Date

October 18, 2009

Last Update Submit

December 23, 2014

Conditions

Coronary Artery Disease

Keywords

rosuvastatin

Outcome Measures

Primary Outcomes (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)

    12months

Secondary Outcomes (4)

  • VH-IVUS parameters

    12months

  • Conventional IVUS parameters

    12months

  • OCT Sub-study parameters

    12months

  • Serum biomarkers

    12months

Study Arms (2)

Rosuvastatin calcium 40mg

EXPERIMENTAL

high-dose (40mg rosuvastatin)

Drug: Rosuvastatin calcium 40mg

Rosuvastatin calcium10mg

ACTIVE COMPARATOR

low-dose statin (10mg rosuvastatin)

Drug: Rosuvastatin calcium10mg

Interventions

Rosuvastatin calcium 40mgDRUG

Rosuvastatin calcium 40mg

Also known as: CRESTOR® 40mg
Rosuvastatin calcium 40mg
Rosuvastatin calcium10mgDRUG

Rosuvastatin 10mg

Also known as: CRESTOR® 10mg
Rosuvastatin calcium10mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Republic of Korea, 138-736, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 28679524DERIVED

  • 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.

    PMID: 27081016DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Seung-Jung Park, MD,PhD

    Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine

Study Record Dates

First Submitted

October 18, 2009

First Posted

October 19, 2009

Study Start

April 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 25, 2014

Record last verified: 2014-12

Locations

KR(1)