The Effects of Pravastatin and Rosuvastatin on Coronary Plaques in Patients With Stable Angina Pectoris

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2011 by Yokohama City University Medical Center
Sponsor:
Information provided by:
Yokohama City University Medical Center
ClinicalTrials.gov Identifier:
NCT01325818
First received: March 28, 2011
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

The purpose of this study is to compare the effects of pravastatin and rosuvastatin on coronary plaque characteristics in patients with stable angina pectoris.


Condition Intervention Phase
Coronary Disease
Hypercholesterolemia
Drug: pravastatin, rosuvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Pravastatin and Rosuvastatin on the Tissue Characteristics and Morphology of Coronary Plaques in Patients With Stable Angina Pectoris

Resource links provided by NLM:


Further study details as provided by Yokohama City University Medical Center:

Primary Outcome Measures:
  • the percent change in fibrous cap thickness by optical coherence tomography [ Time Frame: 9-11 months ] [ Designated as safety issue: Yes ]
    the percent change in fibrous cap thickness by optical coherence tomography


Secondary Outcome Measures:
  • the percent change and the absolute change from baseline in coronary plaque volume and IB signal obtained by IB-IVUS [ Time Frame: 9-11 months ] [ Designated as safety issue: Yes ]
    the percent change and the absolute change from baseline in coronary plaque volume, the percent change in integrated backscatter signal obtained by integrated backscatter IVUS

  • the absolute change from baseline in number of TCFA and plaque rupture, and in neointima thickness on stent struts by OCT [ Time Frame: 9-11 months ] [ Designated as safety issue: Yes ]
    the absolute change from baseline in number of TCFA, plaque rupture, thrombus, calcification, and in neointima thickness on stent struts by optical coherence tomography

  • the percent change and the absolute change from baseline in total cholesterol and LDL cholesterol [ Time Frame: 9-11 months ] [ Designated as safety issue: Yes ]
    the percent change and the absolute change from baseline in total cholesterol and low-density lipoprotein cholesterol


Estimated Enrollment: 150
Study Start Date: March 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1:pravastatin, 2:rosuvastatin
  1. Active Comparator Drug:pravastatin
  2. Active Comparator Drug:rosuvastatin
Drug: pravastatin, rosuvastatin
  1. Active Comparator Intervention: Drug: pravastatin 10mg/day or 20mg/day
  2. Active Comparator Intervention: Drug: rosuvastatin 20mg/day

Detailed Description:

Previous mega trials have demonstrated that lipid-lowering therapy with HMG-CoA reductase inhibitors in individuals with high risk of cardiovascular disease reduces the incidence of coronary heart disease. NCEP ATP-III has suggested the advantage of more intensive lipid lowering therapy with a goal of reducing LDL-C below 70 mg/dL for such patients categorized as very high risk. In Japan, Japan Atherosclerosis Society (JAS) Guidelines for Diagnosis and Treatment of Atherosclerotic Cardiovascular Diseases 2002 have recommended that an LDL-C goal for patients with coronary heart disease (CHD) should be below 100 mg/dL. However, there is no satisfactory evidence whether the investigators need to lower LDL-C level less than the 70mg/dL or not in Japanese population.

Recently, research on diagnosis of coronary plaque has shown significant advances. The REVERSAL study in patients with a history of CHD, by diagnosis with intravascular ultrasound (IVUS), suggested that intensive lipid lowering therapy with atorvastatin (80 mg/day) was associated with no growth of plaque (-0.4% compared to baseline), whereas therapy with pravastatin (40 mg/day) showed a slight increase (2.7%) in plaque volume over 18 months in Western population.

MEGA study has shown that lipid lowering therapy with pravastatin (10-20 mg/day) was associated with a 33% reduction in coronary heart disease incidence as the primary prevention in Japanese patients. However, the effect of lipid lowering therapy in secondary prevention of cardiovascular events is unknown.

Relative plaque regression rate between intensive and moderate lipid lowering therapy would clarify the ideal level of target LDL-C in Japanese population. Furthermore, the different effect on coronary plaque between pravastatin and rosuvastatin which have different LDL-C lowering effect and different affinity to arterial tissue would determine the superior lipid lowering regimen to affect coronary plaque volume.

Therefore, the aim of the present study is to evaluate whether there would be lipid lowering therapy differences in terms of the composition of coronary artery plaques in patients with stable angina pectoris (SAP) using integrated backscatter intravascular ultrasound (IB-IVUS) and optical coherence tomography (OCT).

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who have been diagnosed as stable angina pectoris, and successful percutaneous coronary intervention (PCI) were performed with intravascular ultrasound (IVUS) and optical coherence tomography (OCT) guidance.
  2. Patients having coronary plaques (≧ 500 µm in thickness or % plaque of 20% or more at ≧ 5 mm distal or proximal to the previously treated area in the same branch of coronary artery.
  3. Patients with dyslipidemia as defined by any of the following criteria:

    • TC ≧ 220 mg/dL
    • LDL-C ≧ 140 mg/dL
    • Cholesterol-lowering treatment is allowed according to the investigator's judgment when LDL-C ≧ 100 mg/dL or TC ≧ 180mg/dL.
    • Patients who are under cholesterol-lowering treatment and LDL-C ≦ 120 mg/dL
  4. Patients 20 years or older at the time of their consent.
  5. Patients with written consent by their own volition after being provided sufficient explanation for their participation in this clinical trial.

Exclusion Criteria:

  1. Patients with bypass graft or in-stent restenosis at the site of PCI.
  2. Patients who received PCI in the past on the lesion where the evaluation of coronary plaque volume is planned.
  3. Patients who had plaques in a non-culprit site and might receive PCI during the treatment period.
  4. Patients receiving lipid-lowering drugs (fibrates, probucol, nicotinic acid, cholestyramine or cholesterol absorption inhibitors).
  5. Patients with familial hypercholesterolemia.
  6. Patients with cardiogenic shock.
  7. Patients receiving cyclosporine.
  8. Patients with any allergy to pravastatin and rosuvastatin.
  9. Patients with hepatobiliary disorders.
  10. Pregnant women, women suspected of being pregnant, or lactating women.
  11. Patients with renal disorders (Cr≧2.0mg/dL) or undergoing dialysis.
  12. Patients who are ineligible in the opinion of the investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325818

Contacts
Contact: Kenichiro Saka 81-45-261-5656 Ken_saka@yokohama-cu.ac.jp

Locations
Japan
Yokohama City University Medical Center Recruiting
Yokohama, Japan
Contact: Kenichiro Saka    81-45-261-5656    Ken_saka@yokohama-cu.ac.jp   
Principal Investigator: Kenichiro Saka         
Sponsors and Collaborators
Yokohama City University Medical Center
Investigators
Study Chair: Kiyoshi Hibi Yokohama City University Medical Center
  More Information

No publications provided

Responsible Party: Yokohama City University Medical Center, Cardiovascular Center, Yokohama City University Medical Center
ClinicalTrials.gov Identifier: NCT01325818     History of Changes
Other Study ID Numbers: YCUMC20110324
Study First Received: March 28, 2011
Last Updated: March 31, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by Yokohama City University Medical Center:
Coronary Artery Disease
Coronary Disease
Dyslipidemia
Stable Angina Pectoris
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases Pravastatin
Rosuvastatin
Anticholesteremic Agents
Antilipemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Coronary Artery Disease
Coronary Disease
Hypercholesterolemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Dyslipidemias
Heart Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Molecular Mechanisms of Pharmacological Action
Pravastatin
Rosuvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014