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Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque (CAROTID-STABIL)

2026年5月8日 更新者：Ossama Mansour、Middle East North Africa Stroke and Interventional Neurotherapies Organization

Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Trial With High-Resolution Vessel-Wall MRI and Clinical Endpoints

CAROTID-STABILISE is a phase III, multicentre, randomised, double-blind, placebo-controlled trial evaluating whether alirocumab 150 mg subcutaneously every 2 weeks, added to high-intensity statin therapy, produces greater reduction in intraplaque haemorrhage (IPH) volume at 26 weeks compared with placebo in patients with recently symptomatic carotid stenosis of 50-69% harbouring IPH or lipid-rich necrotic core (LRNC) on high-resolution vessel-wall MRI. The study will enroll 280 participants across multiple centres with a 52-week extension for durability and clinical endpoints assessment.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

BACKGROUND: Symptomatic carotid stenosis of 50-69% carries a 30-day recurrent-stroke risk of 5-8% and a 2-year risk of 15-20% on best medical therapy alone. A substantial proportion of patients are either surgically deferred or anatomically borderline where revascularisation benefit is debated. PCSK9 inhibitors have demonstrated carotid plaque regression, reduction in lipid-rich necrotic core, and reduction in arterial inflammation. However, no RCT has tested whether PCSK9 inhibition can reduce intraplaque haemorrhage or LRNC in symptomatic carotid plaque.

DESIGN: This is a phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group superiority trial with a 26-week primary endpoint assessment and a 52-week extension. Patients with recently symptomatic carotid stenosis (50-69%) with MRI-confirmed vulnerable plaque features (IPH or LRNC) will be randomised 1:1 to alirocumab 150 mg SC q2w or matched placebo, both on background high-intensity statin therapy.

PRIMARY ENDPOINT: Absolute change in IPH volume (mm³) from baseline to week 26, measured on MPRAGE sequences by a blinded central imaging core lab using semi-automated segmentation.

SECONDARY ENDPOINTS: Include percent change in LRNC volume, absolute change in minimum fibrous cap thickness, percent change in total plaque wall volume at weeks 26 and 52, composite of ipsilateral recurrent stroke or TIA through week 52, and proportion avoiding carotid revascularisation through week 52.

SAFETY: Monitored by an independent Data and Safety Monitoring Board (DSMB) with pre-specified interim analyses at 50% and 75% enrolment.

研究の種類

介入

入学 (推定)

280

段階

  • フェーズ 3

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。

研究場所

  • エジプト
      • Alexandria、エジプト
        • Alexandria University, Smouha University Comprehensive Stroke Center
      • Cairo、エジプト
        • Cairo University
      • Cairo、エジプト
        • Ain Shams University
      • Cairo、エジプト
        • Neurology Department, Al-Azhar University
  • カタール
      • Doha、カタール
        • Weill Cornell Medicine-Qatar
  • サウジアラビア
      • Abhā、サウジアラビア
        • King Khalid University
      • Jeddah、サウジアラビア
        • King Abdulaziz Medical City
      • Mecca、サウジアラビア
        • King Abdullah Medical City
  • チュニジア
      • Tunis、チュニジア
        • Institut National de Neurologie
  • トルコ（Türkiye）
      • Eskişehir、トルコ（Türkiye）
        • Department of Neurology, Eskisehir Osmangazi University
      • Istanbul、トルコ（Türkiye）
        • Neurology Department, Dr. Lutfi Kirdar City Hospital
  • パキスタン
      • Karachi、パキスタン
        • Aga Khan University
  • モロッコ
      • Rabat、モロッコ
        • Centre Hospitalier Universitaire Ibn Sina de Rabat
  • ヨルダン
      • Amman、ヨルダン
        • Amman Specialized IR Center

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:

  1. Age ≥ 40 and ≤ 80 years
  2. Recently symptomatic (TIA, amaurosis fugax, or non-disabling ischaemic stroke with mRS ≤ 2) referable to a carotid territory within 28 days of randomisation
  3. Ipsilateral extracranial internal carotid artery stenosis of 50-69% by NASCET criteria on CTA or DSA
  4. HR-VW-MRI evidence of IPH (MPRAGE hyperintensity ≥150% of adjacent sternocleidomastoid) OR LRNC ≥ 10% of plaque volume in the symptomatic plaque
  5. On a stable dose of high-intensity statin (atorvastatin 40-80 mg or rosuvastatin 20-40 mg) for ≥ 4 weeks, or able and willing to initiate atorvastatin 80 mg daily at randomisation
  6. LDL-C ≥ 70 mg/dL (1.8 mmol/L) at screening
  7. Able to undergo 3T MRI (no contraindications)
  8. Provides written informed consent

Exclusion Criteria:

  1. Indication for urgent carotid revascularisation within 14 days per treating team
  2. Disabling stroke (mRS > 2) or NIHSS > 5 at randomisation
  3. Carotid stenosis ≥ 70% or occlusion
  4. Cardioembolic stroke source (atrial fibrillation, LV thrombus, endocarditis, PFO with high-risk features)
  5. Intracranial haemorrhage within 12 months or any history of symptomatic ICH
  6. eGFR < 30 mL/min/1.73 m²
  7. Active hepatobiliary disease or ALT/AST > 3x ULN
  8. Prior exposure to any PCSK9 inhibitor or inclisiran within 6 months
  9. Known hypersensitivity to alirocumab or excipients
  10. Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential
  11. Life expectancy < 24 months
  12. Participation in another interventional trial within 30 days
  13. Inability to comply with follow-up or MRI schedule

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：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Alirocumab + High-Intensity Statin
Alirocumab 150 mg subcutaneous injection every 2 weeks via pre-filled pen, self-administered or caregiver-administered, from randomisation through week 52. Plus atorvastatin 80 mg daily (or rosuvastatin 40 mg if intolerant) as background therapy.
薬：Alirocumab
Alirocumab 150 mg subcutaneous injection every 2 weeks via pre-filled pen for 52 weeks. First dose given at randomisation visit under supervision. Self-administered or caregiver-administered at home for subsequent doses. Alirocumab is a fully human monoclonal antibody that inhibits PCSK9, leading to significant LDL-C reduction beyond that achieved with statins alone.
薬：Placebo
Matched placebo subcutaneous injection every 2 weeks via pre-filled pen for 52 weeks. Visually identical to alirocumab injection. First dose given at randomisation visit under supervision. Self-administered or caregiver-administered at home for subsequent doses.
薬：Atorvastatin
Atorvastatin 80 mg oral tablet once daily as background high-intensity statin therapy for both arms. Rosuvastatin 40 mg daily may be substituted if patient is intolerant to atorvastatin. Administered throughout the entire study duration (52 weeks).
プラセボコンパレーター：Placebo + High-Intensity Statin
Matched placebo subcutaneous injection every 2 weeks via pre-filled pen from randomisation through week 52, visually identical to alirocumab. Plus atorvastatin 80 mg daily (or rosuvastatin 40 mg if intolerant) as background therapy.
薬：Alirocumab
Alirocumab 150 mg subcutaneous injection every 2 weeks via pre-filled pen for 52 weeks. First dose given at randomisation visit under supervision. Self-administered or caregiver-administered at home for subsequent doses. Alirocumab is a fully human monoclonal antibody that inhibits PCSK9, leading to significant LDL-C reduction beyond that achieved with statins alone.
薬：Placebo
Matched placebo subcutaneous injection every 2 weeks via pre-filled pen for 52 weeks. Visually identical to alirocumab injection. First dose given at randomisation visit under supervision. Self-administered or caregiver-administered at home for subsequent doses.
薬：Atorvastatin
Atorvastatin 80 mg oral tablet once daily as background high-intensity statin therapy for both arms. Rosuvastatin 40 mg daily may be substituted if patient is intolerant to atorvastatin. Administered throughout the entire study duration (52 weeks).

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
Absolute change in intraplaque haemorrhage (IPH) volume from baseline to week 26
時間枠：Baseline to 26 weeks
Absolute change in intraplaque haemorrhage volume (mm³) from baseline to week 26, measured on MPRAGE sequences by a blinded central imaging core laboratory using semi-automated segmentation. IPH is defined as hyperintensity ≥150% of adjacent sternocleidomastoid muscle signal on 3T MRI.
Baseline to 26 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Percent change in lipid-rich necrotic core (LRNC) volume at week 26
時間枠：Baseline to 26 weeks
Percent change in lipid-rich necrotic core volume from baseline to week 26, measured on high-resolution vessel-wall MRI by a blinded central imaging core laboratory.
Baseline to 26 weeks
Absolute change in minimum fibrous cap thickness at week 26
時間枠：Baseline to 26 weeks
Absolute change in minimum fibrous cap thickness (mm) from baseline to week 26, measured on post-contrast T1 black-blood MRI by a blinded central imaging core laboratory.
Baseline to 26 weeks
Percent change in total plaque wall volume at week 26
時間枠：Baseline to 26 weeks
Percent change in total plaque wall volume (outer wall area minus lumen area summed across all slices) from baseline to week 26, measured on high-resolution vessel-wall MRI by a blinded central imaging core laboratory.
Baseline to 26 weeks
Percent change in intraplaque haemorrhage (IPH) volume at week 52
時間枠：Baseline to 52 weeks
Percent change in intraplaque haemorrhage volume from baseline to week 52, measured on MPRAGE sequences by a blinded central imaging core laboratory.
Baseline to 52 weeks
Percent change in lipid-rich necrotic core (LRNC) volume at week 52
時間枠：Baseline to 52 weeks
Percent change in lipid-rich necrotic core volume from baseline to week 52, measured on high-resolution vessel-wall MRI by a blinded central imaging core laboratory.
Baseline to 52 weeks
Composite of ipsilateral recurrent ischaemic stroke or TIA through week 52
時間枠：Randomisation to 52 weeks
Time to first occurrence of ipsilateral recurrent ischaemic stroke or transient ischaemic attack (TIA) from randomisation through week 52, adjudicated by an independent blinded clinical events committee.
Randomisation to 52 weeks
Proportion of patients avoiding carotid revascularisation through week 52
時間枠：Randomisation to 52 weeks
Proportion of patients who do not undergo carotid revascularisation (carotid endarterectomy or carotid artery stenting) through 52 weeks from randomisation, adjudicated by an independent blinded clinical events committee.
Randomisation to 52 weeks

その他の成果指標

結果測定
メジャーの説明
時間枠
Safety and tolerability composite
時間枠：Randomisation to 52 weeks
Composite safety endpoint including: serious adverse events, adverse events leading to discontinuation, injection-site reactions, new-onset diabetes, neurocognitive adverse events, frequency of LDL-C < 15 mg/dL and clinical correlates, haemorrhagic stroke, and major bleeding (BARC >= 3). Monitored continuously through 52 weeks.
Randomisation to 52 weeks

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。

スポンサー

Middle East North Africa Stroke and Interventional Neurotherapies Organization

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)

2027年7月1日

一次修了 (推定)

2030年3月1日

研究の完了 (推定)

2030年9月1日

試験登録日

最初に提出

2026年5月8日

QC基準を満たした最初の提出物

2026年5月8日

最初の投稿 (実際)

2026年5月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月14日

QC基準を満たした最後の更新が送信されました

2026年5月8日

最終確認日

2026年5月1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

  • MENASINO-CAROTID-2026-01

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?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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。

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