The Effects of Pravastatin and Rosuvastatin on Coronary Plaques in Patients With Stable Angina Pectoris
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|ClinicalTrials.gov Identifier: NCT01325818|
Recruitment Status : Unknown
Verified March 2011 by Yokohama City University Medical Center.
Recruitment status was: Recruiting
First Posted : March 30, 2011
Last Update Posted : April 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Coronary Disease Hypercholesterolemia||Drug: pravastatin, rosuvastatin||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Pravastatin and Rosuvastatin on the Tissue Characteristics and Morphology of Coronary Plaques in Patients With Stable Angina Pectoris|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||March 2011|
|Estimated Study Completion Date :||February 2016|
Active Comparator: 1:pravastatin, 2:rosuvastatin
Drug: pravastatin, rosuvastatin
- the percent change in fibrous cap thickness by optical coherence tomography [ Time Frame: 9-11 months ]the percent change in fibrous cap thickness by optical coherence tomography
- 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 ]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 ]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 ]the percent change and the absolute change from baseline in total cholesterol and low-density lipoprotein cholesterol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325818
|Contact: Kenichiro Saka||81-45-261-5656||Ken_saka@yokohama-cu.ac.jp|
|Yokohama City University Medical Center||Recruiting|
|Contact: Kenichiro Saka 81-45-261-5656 Ken_saka@yokohama-cu.ac.jp|
|Principal Investigator: Kenichiro Saka|
|Study Chair:||Kiyoshi Hibi||Yokohama City University Medical Center|