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

NCT01325818 | Unknown Phase 4 DMC

• 1 other identifier: YCUMC20110324
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Disease; Hypercholesterolemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• the percent change in fibrous cap thickness by optical coherence tomography

  the percent change in fibrous cap thickness by optical coherence tomography

  9-11 months

Secondary Outcomes (3)

• the percent change and the absolute change from baseline in coronary plaque volume and IB signal obtained by IB-IVUS

  9-11 months

• the absolute change from baseline in number of TCFA and plaque rupture, and in neointima thickness on stent struts by OCT

  9-11 months

• the percent change and the absolute change from baseline in total cholesterol and LDL cholesterol

  9-11 months

Study Arms (1)

1:pravastatin, 2:rosuvastatin

ACTIVE COMPARATOR

1. Active Comparator Drug:pravastatin 2. Active Comparator Drug:rosuvastatin

Drug: pravastatin, rosuvastatin

Interventions

pravastatin, rosuvastatin DRUG

1. Active Comparator Intervention: Drug: pravastatin 10mg/day or 20mg/day 2. Active Comparator Intervention: Drug: rosuvastatin 20mg/day

1:pravastatin, 2:rosuvastatin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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
• Patients 20 years or older at the time of their consent.
• Patients with written consent by their own volition after being provided sufficient explanation for their participation in this clinical trial.

You may not qualify if:

• Patients with bypass graft or in-stent restenosis at the site of PCI.
• Patients who received PCI in the past on the lesion where the evaluation of coronary plaque volume is planned.
• Patients who had plaques in a non-culprit site and might receive PCI during the treatment period.
• Patients receiving lipid-lowering drugs (fibrates, probucol, nicotinic acid, cholestyramine or cholesterol absorption inhibitors).
• Patients with familial hypercholesterolemia.
• Patients with cardiogenic shock.
• Patients receiving cyclosporine.
• Patients with any allergy to pravastatin and rosuvastatin.
• Patients with hepatobiliary disorders.
• Pregnant women, women suspected of being pregnant, or lactating women.
• Patients with renal disorders (Cr≧2.0mg/dL) or undergoing dialysis.
• Patients who are ineligible in the opinion of the investigator.

Sponsors & Collaborators

• Yokohama City University Medical Center: lead

Study Sites (1)

Yokohama City University Medical Center

Yokohama, Japan

RECRUITING

MeSH Terms

Conditions

Coronary Disease; Hypercholesterolemia; Coronary Artery Disease; Dyslipidemias; Angina, Stable; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Interventions

Pravastatin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases; Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kiyoshi Hibi

  Yokohama City University Medical Center

  STUDY CHAIR

Central Study Contacts

Kenichiro Saka

CONTACT

81-45-261-5656; Ken_saka@yokohama-cu.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: March 30, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: February 1, 2016
• Last Updated: April 1, 2011

Record last verified: 2011-03

Locations

JP (1)