Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-20 @ 3:37 PM
Study NCT ID:
NCT01325818
Status:
UNKNOWN
Last Update Posted:
2011-04-01
First Post:
2011-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Pravastatin and Rosuvastatin on Coronary Plaques in Patients With Stable Angina Pectoris
Sponsor:
Yokohama City University Medical Center
Organization:
Study Overview
Official Title:
The Effects of Pravastatin and Rosuvastatin on the Tissue Characteristics and Morphology of Coronary Plaques in Patients With Stable Angina Pectoris
Status:
UNKNOWN
Status Verified Date:
2011-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: