The Effects of Pravastatin and Rosuvastatin on Coronary Plaques in Patients With Stable Angina Pectoris
The Effects of Pravastatin and Rosuvastatin on the Tissue Characteristics and Morphology of Coronary Plaques in Patients With Stable Angina Pectoris
調査の概要
詳細な説明
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).
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Kenichiro Saka
- 電話番号：81-45-261-5656
- メール：Ken_saka@yokohama-cu.ac.jp
研究場所
-
-
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Yokohama、日本
- 募集
- Yokohama City University Medical Center
-
コンタクト：
- Kenichiro Saka
- 電話番号：81-45-261-5656
- メール：Ken_saka@yokohama-cu.ac.jp
-
主任研究者：
- Kenichiro Saka
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：1:pravastatin, 2:rosuvastatin
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
the percent change in fibrous cap thickness by optical coherence tomography
時間枠：9-11 months
|
the percent change in fibrous cap thickness by optical coherence tomography
|
9-11 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
the percent change and the absolute change from baseline in coronary plaque volume and IB signal obtained by IB-IVUS
時間枠：9-11 months
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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
|
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the absolute change from baseline in number of TCFA and plaque rupture, and in neointima thickness on stent struts by OCT
時間枠：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
|
9-11 months
|
|
the percent change and the absolute change from baseline in total cholesterol and LDL cholesterol
時間枠：9-11 months
|
the percent change and the absolute change from baseline in total cholesterol and low-density lipoprotein cholesterol
|
9-11 months
|
協力者と研究者
捜査官
- スタディチェア：Kiyoshi Hibi、Yokohama City University Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- YCUMC20110324
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