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

Hypercholesterolemia Clinical Trial

Official title:

The Effects of Pravastatin and Rosuvastatin on the Tissue Characteristics and Morphology of Coronary Plaques in Patients With Stable Angina Pectoris

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01325818
• Other study ID #: YCUMC20110324
• Status: Recruiting
• Phase: Phase 4
• First received: March 28, 2011
• Last updated: March 31, 2011
• Start date: March 2011
• Est. completion date: February 2016

Study information

• Verified date: March 2011
• Source: Yokohama City University Medical Center
• Contact: Kenichiro Saka
• Phone: 81-45-261-5656
• Email: Ken_saka[@]yokohama-cu.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2016
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Hypercholesterolemia

Intervention

Drug:
• pravastatin, rosuvastatin
Active Comparator Intervention: Drug: pravastatin 10mg/day or 20mg/day Active Comparator Intervention: Drug: rosuvastatin 20mg/day

Locations

Country	Name	City	State
Japan	Yokohama City University Medical Center	Yokohama

Sponsors (1)

Lead Sponsor	Collaborator
Yokohama City University Medical Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	the percent change and the absolute change from baseline in coronary plaque volume and IB signal obtained by IB-IVUS	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	9-11 months	Yes
Secondary	the absolute change from baseline in number of TCFA and plaque rupture, and in neointima thickness on stent struts by OCT	the absolute change from baseline in number of TCFA, plaque rupture, thrombus, calcification, and in neointima thickness on stent struts by optical coherence tomography	9-11 months	Yes
Secondary	the percent change and the absolute change from baseline in total cholesterol and LDL cholesterol	the percent change and the absolute change from baseline in total cholesterol and low-density lipoprotein cholesterol	9-11 months	Yes