Early Intensive Lipid-Lowering With Inclisiran for Plaque Stabilization in Acute Coronary Syndrome (SEsiR-ACS)
2026年8月28日 更新者：Chang-Hwan Yoon、Seoul National University Bundang Hospital
Statin, Ezetimibe, and Inclisiran for Plaque Regression in Acute Coronary Syndrome: A Randomized Controlled Trial (SEsiR-ACS Trial)
This multicenter, randomized, open-label clinical trial will evaluate whether an early intensive lipid-lowering strategy can improve coronary plaque stabilization in patients hospitalized with acute coronary syndrome. A total of 294 participants will be randomly assigned in a 1:1 ratio to either an early intensive treatment strategy with a high-intensity statin, ezetimibe, and inclisiran, or a guideline-based stepwise lipid-lowering strategy.
Coronary plaque characteristics will be assessed using optical coherence tomography (OCT) at baseline and at 12 months. The primary outcome is the change in minimal fibrous cap thickness from baseline to 12 months. Additional assessments will include other OCT-based plaque characteristics, lipid levels, safety outcomes, and, in a subset of participants, intravascular ultrasound measurements of plaque burden.
調査の概要
研究の種類
介入
入学 (推定)
294
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Chang-Hwan Yoon, MD, PhD
- 電話番号：+82-031-787-7019
- メール：changhwanyoon@gmail.com
研究場所
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Gyeonggi-do
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Seongnam-si、Gyeonggi-do、韓国、13620
- Seoul National University Bundang Hospital
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コンタクト：
- Chang-Hwan Yoon
- 電話番号：+82-031-787-7019
- メール：changhwanyoon@gmail.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age 19 to 85 years.
- Hospitalization for acute coronary syndrome (UA, NSTEMI, or STEMI) with planned coronary angiography and PCI, or PCI already performed during the index hospitalization with adequate baseline OCT images obtained during the procedure that meets the study imaging analysis criteria.
- Presence of a target vessel/segment considered by the investigator to be suitable for OCT assessment at baseline and at the 12-month follow-up.
LDL-C level at screening meeting one of the following criteria according to background lipid-lowering therapy:
i) ≥40 mg/dL in patients receiving stable combination therapy with a statin and ezetimibe, defined as no dose change for at least 4 weeks before screening; ii) ≥55 mg/dL in patients receiving high-intensity statin therapy; iii) ≥70 mg/dL in patients receiving low- or moderate-intensity statin therapy; or iv) ≥100 mg/dL in patients not receiving stable statin therapy.
- Provision of voluntary written informed consent after receiving sufficient information regarding the study objectives, procedures, and follow-up plan.
Exclusion Criteria:
- Severe hepatic dysfunction, defined as AST or ALT >3 times the upper limit of normal.
- CK >5 times the upper limit of normal or suspected clinically significant myopathy.
- Severe renal impairment, defined as eGFR <30 mL/min/1.73 m².
- Severe hypersensitivity to or contraindication to statins, ezetimibe, or inclisiran.
- Pregnancy, breastfeeding, or plans to become pregnant during the study period.
- Inability to undergo 12-month follow-up coronary angiography and OCT.
- Life expectancy <1 year or, in the investigator's judgment, inappropriate participation in the study because of concerns regarding adherence or safety.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Early Intensive Lipid-Lowering Strategy
Participants will receive an early intensive lipid-lowering strategy consisting of a high-intensity statin, ezetimibe 10 mg once daily, and inclisiran 284 mg by subcutaneous injection initiated during the index hospitalization or as early as feasible.
Inclisiran will be repeated at 3 months and 9 months.
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Inclisiran sodium 284 mg/1.5 mL will be administered by subcutaneous injection in the early intensive lipid-lowering group.
Inclisiran will be initiated during the index hospitalization or as early as feasible thereafter, within 2 weeks, followed by additional doses at 3 months (±2 weeks) and 9 months (±2 weeks).
High-intensity statin therapy will consist of atorvastatin 40-80 mg orally once daily or rosuvastatin 20 mg orally once daily, or the maximally tolerated dose.
High-intensity statin therapy will be initiated or continued during the index hospitalization in both treatment groups.
Ezetimibe 10 mg will be administered orally once daily.
In the early intensive lipid-lowering group, ezetimibe will be initiated during the index hospitalization.
In the guideline-based stepwise intensification group, ezetimibe will be added according to follow-up LDL-C levels if the treatment target is not achieved with high-intensity statin therapy.
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アクティブコンパレータ：Guideline-Based Stepwise Intensification Strategy
Participants will receive a guideline-based stepwise lipid-lowering strategy.
High-intensity statin therapy will be initiated or continued during the index hospitalization.
Ezetimibe will be added according to follow-up LDL-C levels, and a PCSK9 inhibitor may be considered if the LDL-C target remains unmet.
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High-intensity statin therapy will consist of atorvastatin 40-80 mg orally once daily or rosuvastatin 20 mg orally once daily, or the maximally tolerated dose.
High-intensity statin therapy will be initiated or continued during the index hospitalization in both treatment groups.
Ezetimibe 10 mg will be administered orally once daily.
In the early intensive lipid-lowering group, ezetimibe will be initiated during the index hospitalization.
In the guideline-based stepwise intensification group, ezetimibe will be added according to follow-up LDL-C levels if the treatment target is not achieved with high-intensity statin therapy.
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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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Change in Minimal Fibrous Cap Thickness
時間枠：Baseline to 12 months
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Change from baseline to 12 months in minimal fibrous cap thickness (FCT), measured by optical coherence tomography (OCT) in one prespecified representative matched non-stented coronary plaque or segment per participant.
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Baseline to 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 |
|---|---|---|
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Change in OCT-Derived Lipid Plaque Characteristics
時間枠：Baseline to 12 months
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Changes from baseline to 12 months in maximum lipid arc, mean lipid arc, lipid length, lipid index, and the prevalence of thin-cap fibroatheroma (TCFA), assessed by optical coherence tomography (OCT) in matched non-stented coronary plaque segments.
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Baseline to 12 months
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Change in Lipid Parameters and LDL-C Target Attainment
時間枠：Baseline to 12 months
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Absolute and percentage changes in LDL-C from baseline during follow-up, achievement of the prespecified LDL-C target, defined as LDL-C <40 mg/dL and a reduction of at least 50% from baseline, and changes in non-HDL-C, hsCRP, and, when available, ApoB and Lp(a).
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Baseline to 12 months
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Changes in IVUS-Derived Plaque Burden in the IVUS Substudy
時間枠：Baseline to 12 months
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Change from baseline to 12 months in percent atheroma volume (PAV), assessed by intravascular ultrasound (IVUS) in matched non-stented coronary segments.
Additional IVUS assessments include changes in total atheroma volume (TAV) and plaque burden.
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Baseline to 12 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Exploratory Clinical Events
時間枠：Up to 12 months
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Exploratory clinical events will include cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, unplanned revascularization, and hospitalization.
Event numbers and cumulative incidence rates will be assessed during follow-up.
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Up to 12 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2029年9月1日
研究の完了 (推定)
2029年9月1日
試験登録日
最初に提出
2026年8月28日
QC基準を満たした最初の提出物
2026年8月28日
最初の投稿 (実際)
2026年9月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月2日
QC基準を満たした最後の更新が送信されました
2026年8月28日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- B-2607-1057-003
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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いいえ
米国FDA規制機器製品の研究
いいえ
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