Ezetimibe In Addition To Atorvastatin Therapy On The Plaque Composition In Patients With Acute Myocardial Infarction. (OCTIVUS)
The Effect Of Ezetimibe In Addition To Optimal Cholesterol-Lowering Statin Therapy On The Plaque Composition In Patients With Acute Myocardial Infarction - Assessed By Optical Coherence Tomography And Intravascular Ultrasound.
The purpose of the study is to examine the effect of the cholesterol lowering agent Ezetimibe when used in addition to optimal treatment with Atorvastatin in patients with acute ST-Elevation Myocardial Infarction (STEMI) who have not been in prior statin therapy.
An area with arteriosclerosis not demanding intervention in a coronary vessel other than the infarct related is used as measuring point and is examined at time of the infarction and after 12 month using intravascular ultrasound and optical coherence tomography. At the same time the same techniques are used to examine the implanted stent.
調査の概要
詳細な説明
Optical coherence tomography (OCT) and intravascular ultrasound (IVUS) with tissue characterization (IVUS-TC) are relatively new expansions to intravascular assessments, and has the capacity to assess plaque composition and, potentially, to identify vulnerable plaques. One of the mechanisms by which statins improve patient outcomes may be by changing the composition of a "vulnerable" plaque. The main effect is believed to rely on a lowering of LDL-c. The question is whether a further reduction of LDL by adding ezetimibe to optimal cholesterol lowering therapy using statins may result in further plaque stabilization or reduction. This is the hypothesis of the current study.
100 patients are randomized to Ezetimibe 10 mg per day or placebo. All patients are treated with Atorvastatin 80 mg. OCT and IVUS are performed at inclusion (typically the day after Primary PCI) and again at follow-up after 12 month.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Odense C、デンマーク、5000
- Department of Cardiology, Odense University Hospital
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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:
- ST segment elevation acute myocardial infarction
- 20% < angiographic diameter stenosis < 50% on a not previously revascularized native coronary artery
- Statin naïve
- In fertile women: Ongoing contraception with IUD or hormonal contraception.
Exclusion Criteria:
- Pharmacologic lipid lowering treatment before index hospitalization
- Atrial fibrillation, not well rate-controlled
- Ventricle frequency variation with more than a factor 2 over 1 minute
- Unconscious patients
- History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins) including Atorvastatin.
- Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception or have a positive serum pregnancy test (a serum-human chorionic gonadotrophin [Beta-HCG] analysis)
- History of malignancy (unless a documented disease free period exceeding 5-years is present) with the exception of basal cell or squamous cell carcinoma of the skin. Women with a history of cervical dysplasia would be permitted to enter the study provided they had 3 consecutive clear Papanicolaou (Pap) smears
- Uncontrolled hypothyroidism (TSH > 1.5xULN)
- Abnormal LFT's
- History of alcohol or drug abuse within the last 5 years (this may affect compliance)
- Current active liver disease (ALT/SGPT >2xULN or severe hepatic impairment (to protect patient safety as directed on the labels of currently approved statins)
- Unexplained creatine kinase (CK > 3xULN) (To protect patient safety) (will be increased at baseline because of acute ST segment elevation myocardial infarction a few days before enrolment)
- Serum creatinine >176mmol/L (2.0mg/dL) (unless the protocol specifically aims to investigate a chronic renal disease population)
- Participation in another investigational drug study less than 4 weeks before enrolment in the study, or according to subjects local ethics committee requirements where a larger period is stipulated (to avoid potential misinterpretation of overlapping adverse events)
- Treatments with cyclosporine
- Treatment with gemfibrozil
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：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター：Atorvastatin plus Placebo
50/100 patients are randomized to Atorvastatin 80 mg per day plus placebo.
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100 patients with ST elevation myocardial infarction are randomized 1:1 to either placebo or Ezetimibe 10 mg per day in addition to treatment with Atorvastatin 80 mg in both arms.
他の名前：
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実験的：Atorvastatin plus Ezetimibe
100 patients with ST elevation myocardial infarction are randomized 1:1 to either placebo or Ezetimibe 10 mg per day in addition to treatment with Atorvastatin 80 mg in both arms.
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100 patients with ST elevation myocardial infarction are randomized 1:1 to either placebo or Ezetimibe 10 mg per day in addition to treatment with Atorvastatin 80 mg in both arms.
他の名前：
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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 |
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Plaque volume and composition in a non-significant coronary plaque
時間枠：After 12 months of follow-up
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Plaque volume assessed by intravascular ultrasound and Optical Coherence Tomography
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After 12 months of follow-up
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二次結果の測定
結果測定 |
時間枠 |
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Change in plaque-composition (measured with Tissue Characterization) in a 10 mm segment of a native coronary vessel with a non-significant stenosis where plaque-volume at baseline is greatest.
時間枠：After 12 months of follow-up
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After 12 months of follow-up
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Change in percent of the plaque volume in the native coronary vessel with a non-significant stenosis.
時間枠：After 12 months of follow-up
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After 12 months of follow-up
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Change in percent of the plaque volume in the 10 mm segment of a native coronary vessel with a non-significant lesion where plaque volume at baseline is greatest.
時間枠：After 12 months of follow-up
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After 12 months of follow-up
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Change in absolute numbers of the plaque volume in the 10 mm segment of a native coronary vessel with a non-significant lesion where plaque volume at baseline is greatest.
時間枠：After 12 months of follow-up
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After 12 months of follow-up
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Change in percent of the plaque burden in the 10 mm segment of a native coronary vessel with a non-significant lesion where plaque volume at baseline is greatest.
時間枠：After 12 months of follow-up
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After 12 months of follow-up
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Change in percent of the plaque burden in a native coronary vessel with a non-significant lesion.
時間枠：After 12 months of follow-up
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After 12 months of follow-up
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Incomplete stent apposition.
時間枠：After 12 months of follow-up
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After 12 months of follow-up
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Edge response in stented segment.
時間枠：After 12 months of follow-up
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After 12 months of follow-up
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Stent expansion.
時間枠：After 12 months of follow-up
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After 12 months of follow-up
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Evaluation of the OCT-technique in clinical use compared to IVUS.
時間枠：After 12 months of follow-up
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After 12 months of follow-up
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Evaluation of the Resolute stents effect on neointima growth and apposition.
時間枠：After 12 months of follow-up
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After 12 months of follow-up
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協力者と研究者
捜査官
- 主任研究者：Mikkel Hougaard, MD、Department of Cardiology, Odense University Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Placeboの臨床試験
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Palacky University完了
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Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
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Advice Pharma Group srl積極的、募集していない肥満 | 栄養障害 | 体重 | 減量 | 食生活 | 太りすぎと肥満 | 健康行動 | ダイエット、健康 | ダイエット習慣 | ライフスタイル | 栄養、健康 | 行動障害イタリア
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University Hospital, Strasbourg, France積極的、募集していない