PCSK9 Inhibitor on ACS Patients With Multivessel Disease and Relatively Low LDL-C Level in Chinese Population
Effect of PCSK9 Inhibitor on Acute Coronary Syndrome Patients With Multivessel Disease and Relatively Low LDL-C Level in Chinese Population (CHOICE Study)
The study is an open-label, multicenter, and randomized study. The objective of this study is to demonstrate the effect of PCSK9 inhibitor on ACS patients with multivessel disease and relatively low LDL-C levels or LDL-C levels lower than the recommended target.
The primary outcome was the rate of major adverse cardiac events (CV death, non-fatal myocardial infarction, documented unstable angina that requires admission into a hospital, all coronary revascularization with either PCI or CABG occurring at least 30 days after randomization, Non-fatal stroke) at 1 year. The secondary efficacy endpoints were individual components of the major adverse cardiac events, all cause death, and the percent change in LDL-C, Apo B, HDL-C, Lp(a) after treatment.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
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:
- 40-85 years age;
- Recent hospitalization for acute coronary syndrome
- LDL-C ≤70 mg/dL (≤1.8 mmol/L) in patients who have been receiving stable treatment with moderate- or high-intensity statin within ≥ 4 weeks prior to enrollment (i.e. continuous treatment that has not changed with regard to statin intensity over the past 4 weeks) or, LDL-C ≤90 mg/dL (≤2.3 mmol/L) in patients who have been receiving stable treatment with low-intensity statin within ≥ 4 weeks prior to enrollment (i.e. continuous treatment that has not changed with regard to statin intensity over the past 4 weeks), or LDL-C≤125 mg/dL (≤3.2 mmol/L) in patients who are statin-naïve or have not been on a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment;
- Multivessel disease, defined as ≥50% reduction in lumen diameter of at least three major epicardial coronary arteries by angiographic visual estimation or in major branches of one or more of these arteries, irrespective of the localization (proximal 50mm or more distal localization) of the obstructive lesions
- Patients with written informed consent.
Exclusion Criteria:
- Unstable clinical status (hemodynamic or electrical instability); Uncontrolled cardiac arrhythmia, defined as recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response not controlled by medications in the past 3 months prior to screening;
- Severe renal dysfunction, defined by estimated glomerular filtration rate <30 ml/min/1.73m2;
- Active liver disease or hepatic dysfunction, either reported in patient medical record or defined by asparate aminotransferase (AST) or alanine aminotransferase (ALT) levels > 3x the upper limit of normal;
- Patients who previously received evolocumab or other PCSK9 inhibitor;
- Treatment with systemic steroids or systemic cyclosporine in the past 3 months systemic cyclosporine, systemic steroids (eg. intravenous, intramuscular or per os);
- Known active infection or major hematologic, metabolic, or endocrine dysfunction in the judgment of the Investigator;
- Patients who will not be available for study-required procedures in the judgment of the Investigator;
- Current enrollment in another investigational device or drug study;
- Active malignancy requiring treatment;
- Intolerance of or allergy to statin or PCSK9 inhibitor;
- pregnancy, giving birth within the last 90 days, or lactation.
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 |
|---|---|
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介入なし:Control
Standard of care: management as recommended in ESC/EAS 2019 guidelines, within reimbursement criteria
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実験的:treatment
On top of Standard of care, Evolocumab (Repatha®) 140 mg or Alirocumab(Praluent) 75mg every two weeks: first subcutaneous injection at the time of randomization, followings during 12 months.
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Evolocumab (Repatha®) 140 mg or Alirocumab (Praluent) 75mg every two weeks, first subcutaneous injection at the time of randomization, followings during 12 months
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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Primary Endpoint
時間枠:12 months
|
The primary endpoint in the CHOICE study was the rate of major adverse cardiac events at 1 year. The definition of major adverse cardiac events was a composite of:
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12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Secondary Endpoint
時間枠:12 months
|
The secondary efficacy endpoints were individual components of the major adverse cardiac events, all cause death, and the percent change in LDL-C, Apo B, HDL-C, Lp(a) at 1 year.
|
12 months
|
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Secondary Endpoint
時間枠:12 months
|
the percent change in LDL-C, Apo B, HDL-C, Lp(a) at 1 year.
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12 months
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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