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Reduced-Dose Thrombolysis in Intermediate-Risk Pulmonary Embolism With High-Risk Features (REDUCTION)

2026年11月2日 更新者：China National Center for Cardiovascular Diseases

Reduced-Dose Thrombolysis in Intermediate-High Risk Pulmonary Embolism, a Multicenter, Randomized Controlled Trial

Alteplase, a recombinant tissue plasminogen activator (rt-PA), is commonly used for thrombolytic treatment in patients with high-risk acute pulmonary thromboembolism (PTE), whereas the role of thrombolysis in intermediate-risk PTE remains controversial. This multicenter, randomized controlled trial will compare the efficacy and safety of reduced-dose alteplase (25 mg administered intravenously over 2 hours) plus standard anticoagulation with standard anticoagulation alone in patients with intermediate-risk PTE who have high-risk features.

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

In patients with intermediate-risk pulmonary embolism (PE), full-dose systemic thrombolysis has been associated with a reduction in the risk of hemodynamic decompensation but an increased risk of major and intracranial bleeding. Previous studies suggest that reduced-dose thrombolysis may improve right ventricular (RV) function while potentially reducing bleeding complications. However, evidence regarding the efficacy and safety of reduced-dose systemic thrombolysis in patients with intermediate risk PE and additional high-risk clinical features remains limited. This study aims to evaluate the efficacy and safety of reduced-dose thrombolytic therapy in this patient population.

The REDUCTION study is a multicenter, randomized, open-label, controlled trial with blinded endpoint assessment and long-term follow-up.

Eligible patients will be randomly assigned in a 1:1 ratio to receive reduced-dose alteplase combined with standard anticoagulation or standard anticoagulation alone. Randomization will be centrally managed and stratified by participating center.

Patients will receive:

  • Reduced-dose alteplase group: Alteplase 25 mg administered by intravenous infusion over 2 hours, followed by standard anticoagulation with low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) for at least 5 days.
  • Standard anticoagulation group: Standard anticoagulation with LMWH or UFH for at least 5 days without thrombolytic therapy.

The primary objective is to assess the efficacy of reduced-dose alteplase in improving RV function at 48 hours, as measured by the change in the ratio of right ventricular to left ventricular end-diastolic diameters (RVED/LVED) on echocardiography.

The secondary objectives are to evaluate early changes in right ventricular function, clinical deterioration, PE-related mortality, recurrent PE, and bleeding complications. Long-term assessments will evaluate persistent dyspnea, functional status, persistent right ventricular dysfunction, and the occurrence of chronic thromboembolic pulmonary disease (CTEPD) and chronic thromboembolic pulmonary hypertension (CTEPH)

研究の種類

介入

入学 (推定)

270

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。

研究連絡先

  • 名前：Changming Xiong, Prof.
  • 電話番号：(+86)010-88396798
  • メール：xiongcmfw@163.com

研究場所

  • 中国
      • Beijing、中国、100037
        • Chinese Academy of Medical Sciences, Fuwai Hospital
        • コンタクト：
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100029
        • China-Japan Friendship Hospital
        • コンタクト：
      • Beijing、Beijing Municipality、中国、100730
        • Peking Union Medical College Hospital
        • コンタクト：
          • Juhong Shi, Prof.
          • 電話番号：010-69156114
          • メール：shijh@pumch.cn
      • Beijing、Beijing Municipality、中国、100029
        • Beijing Anzhen Hospital, Capital Medical University
        • コンタクト：
      • Beijing、Beijing Municipality、中国、100020
        • Beijing ChaoYang Hospital.Capital Medical University
        • コンタクト：
    • Guangdong
      • Guangzhou、Guangdong、中国、510120
        • Guangdong Provincial Hospital of Chinese Medicine
        • コンタクト：
      • Guangzhou、Guangdong、中国、510120
        • The First Affiliated Hospital of Guangzhou Medical University / Guangzhou Institute of Respiratory Health (National Clinical Research Center for Respiratory Disease)
        • コンタクト：
      • Shenzhen、Guangdong、中国、518116
        • Longgang Central Hospital of Shenzhen
        • コンタクト：
    • Hebei
      • Zhangjiakou、Hebei、中国、075000
        • The First Affiliated Hospital of Hebei North University
        • コンタクト：
    • Henan
      • Xinxiang、Henan、中国、453400
        • HeNan Honliv Hospital
        • コンタクト：
      • Zhengzhou、Henan、中国、450052
        • The First Affiliated Hospital of Zhengzhou University
        • コンタクト：
      • Zhengzhou、Henan、中国、450003
        • Henan Provincial People's Hospital
        • コンタクト：
    • Hubei
      • Wuhan、Hubei、中国、430015
        • Wuhan Sixth Hospital (Affiliated Hospital of Jianghan University)
        • コンタクト：
    • Inner Mongolia
      • Baotou、Inner Mongolia、中国、014010
        • Inner Mongolia Baogang Hospital
        • コンタクト：
      • Tongliao、Inner Mongolia、中国、028000
        • NMG Keerqin District Hosp.
        • コンタクト：
    • Jiangsu
      • Changzhou、Jiangsu、中国、213003
        • The Second People's Hospital of Changzhou, The Third Affiliated Hospital of Nanjing Medical University
        • コンタクト：
      • Nanjing、Jiangsu、中国、210006
        • Nanjing First Hospital
        • コンタクト：
    • Liaoning
      • Shenyang、Liaoning、中国、110024
        • Central Hospital Affiliated to Shenyang Medical College
        • コンタクト：
          • Shuyue Xia, Prof.
          • 電話番号：024-85715200
          • メール：syx262@126.com
      • Shenyang、Liaoning、中国、110003
        • General Hospital of Northern Theater Command
        • コンタクト：
    • Ningxia
      • Yinchuan、Ningxia、中国、750004
        • Ningxia Medical University General Hospital
        • コンタクト：
    • Shandong
      • Jinan、Shandong、中国、250021
        • Shandong Provincial Hospital
        • コンタクト：
      • Linyi、Shandong、中国、276000
        • Linyi People's Hospital
        • コンタクト：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200120
        • Shanghai East Hospital, School of Medicine, Tongji University
        • コンタクト：
    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • West China Hospital, Sichuan University
        • コンタクト：
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300052
        • Tianjin Medical University General Hospital
        • コンタクト：
      • Tianjin、Tianjin Municipality、中国、300222
        • Tianjin Chest Hospital
        • コンタクト：

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

18年～75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Age 18 to 75 years

  • Objectively confirmed acute pulmonary thromboembolism (PTE) with symptom onset within 14 days, based on at least one of the following:

    1. Ventilation/perfusion lung scan showing at least one segmental or larger mismatched perfusion defect;
    2. Computed tomography pulmonary angiography (CTPA) or pulmonary angiography showing a filling defect or abrupt obstruction in a segmental or more proximal pulmonary artery.

  • Intermediate-high-risk PTE, with both of the following:

    1. Right ventricular dysfunction (RVD) on echocardiography or CTPA. Echocardiographic RVD is defined by at least one of the following:(1) right ventricular dilation with RV/LV end-diastolic diameter ratio >1.0; (2) reduced right ventricular free-wall motion; (3) increased tricuspid regurgitation velocity;(4) tricuspid annular plane systolic excursion <16 mm; (5) tricuspid annular systolic velocity (S') <9.5 cm/s. CTPA evidence of RVD is defined as right ventricular dilation with RV/LV end-diastolic diameter ratio >1.0.
    2. Cardiac injury or heart failure biomarker above the local upper limit of normal, including cardiac troponin, BNP, or NT-proBNP.

  • Elevated risk of early death/hemodynamic collapse, indicated by at least one of the following high-risk features: Systolic blood pressure ≤110 mmHg, Heart rate ≥100 beats/min, Oxygen saturation (SpO₂) <90% (respiratory rate >20 breaths/min or arterial partial pressure of oxygen [PaO₂] <60 mmHg).

  • Signed informed consent

Exclusion Criteria:

  • High-risk PTE with hemodynamic instability, including cardiac arrest, obstructive shock, or persistent hypotension defined as systolic blood pressure <90 mmHg or a decrease of ≥40 mmHg from baseline lasting at least 15 minutes, after excluding hypotension caused by new-onset arrhythmia, hypovolemia, or sepsis.

  • Intermediate-low-risk PTE, defined as hemodynamically stable PE with only one of the following findings: right ventricular dysfunction on imaging or elevated cardiac biomarkers.

  • Low-risk PTE, defined as hemodynamically stable PTE without right ventricular dysfunction and without elevated cardiac injury or heart failure biomarkers.

  • Any contraindication to systemic thrombolysis, including:

    1. Known hypersensitivity to alteplase, gentamicin, heparin, low-molecular-weight heparin, or any component of the study treatment;
    2. Active bleeding or high risk of bleeding;
    3. Known or suspected intracranial hemorrhage;
    4. Suspected subarachnoid hemorrhage or aneurysmal subarachnoid hemorrhage;
    5. Significant bleeding disorder within the previous 6 months;
    6. Known bleeding diathesis;
    7. Acute ischemic stroke or transient ischemic attack within the previous 6 months;
    8. Ophthalmic surgery within the previous 3 months, or abdominal, cardiac, thoracic, vascular, or orthopedic surgery or trauma within the previous 3 months;
    9. History of central nervous system disease or trauma, including tumor, aneurysm, head trauma, intracranial surgery, or spinal surgery;
    10. Platelet count <100 × 10^9/L;
    11. International normalized ratio (INR) >1.3;
    12. Current effective oral anticoagulant treatment;
    13. Traumatic cardiopulmonary resuscitation;
    14. Infective endocarditis or pericarditis;
    15. Acute pancreatitis;
    16. Noncompressible vascular puncture;
    17. Severe uncontrolled hypertension, with systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg;
    18. Any other condition considered by the investigator to confer a high bleeding risk;
    19. Severe liver disease, including liver failure, cirrhosis, portal hypertension, esophageal varices, or active hepatitis;
    20. Gastrointestinal ulcer, esophageal varices, arterial aneurysm, or arteriovenous malformation within the previous 3 months;
    21. Tumor with bleeding tendency;
    22. Pregnancy or within 1 week postpartum;
    23. Diabetes with hemorrhagic retinopathy;

  • Body weight ≤40 kg.

  • Thrombolytic treatment within 30 days before randomization for the current episode of acute PE, including systemic or catheter-directed thrombolysis.

  • Catheter-directed mechanical thrombectomy or surgical pulmonary embolectomy before randomization for the current episode of acute PE.

  • Use of any direct oral anticoagulant within 30 days before randomization.

  • Current dual antiplatelet therapy.

  • Current participation in another interventional clinical trial.

  • Women of childbearing potential who are unwilling to use effective contraception or abstinence during the study.

  • Any other disease or condition that, in the investigator's judgment, would increase treatment risk.

  • Life expectancy <3 months or inability to complete 3-month follow-up.

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
アクティブコンパレータ：Reduced-Dose Alteplase and Standard Anticoagulation

Low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) and reduced-dose alteplase [25 mg continuous intravenous infusion for 2 hours]
薬：Alteplase

Alteplase 25 mg will be administered by continuous intravenous infusion over 2 hours

薬：Standard Anticoagulation

Standard anticoagulation will consist of LMWH or UFH administered according to current guideline recommendations for at least 5 days
アクティブコンパレータ：Standard Anticoagulation

Low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH)
薬：Standard Anticoagulation

Standard anticoagulation will consist of LMWH or UFH administered according to current guideline recommendations for at least 5 days

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
時間枠
Change in the ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter (RVED/LVED) as measured by echocardiography
時間枠：Between baseline and 48 hours
Between baseline and 48 hours

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in the ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter (RVED/LVED) as measured by echocardiography
時間枠：Between baseline and 7 days
Between baseline and 7 days
Clinical Deterioration
時間枠：7 days
7 days
PE-Related Death
時間枠：7 days

Death caused by pulmonary embolism (PE)
7 days
All cause Death
時間枠：7 days
7 days
Recurrent PE
時間枠：7 days
7 days
Persistent Dyspnea
時間枠：6 months

Persistent Dyspnea Assessed by the Medical Research Council (MRC) Dyspnea Scale
6 months
Functional outcome
時間枠：6 months

Functional status will be assessed using the Post-Venous Thromboembolism Functional Status (PVFS) Scale, which measures limitations in usual activities and daily functioning after venous thromboembolism. The scale ranges from grade 0 (no functional limitations) to grade 4 (severe functional limitations requiring assistance with activities of daily living). Higher grades indicate greater functional impairment. Grade D indicates death before the scheduled assessment.
6 months
Persistent Right Ventricular Dysfunction
時間枠：6 months

Persistent right ventricular dysfunction is defined as an intermediate or high probability of pulmonary hypertension on echocardiography according to the European Society of Cardiology (ESC) criteria.
6 months
Chronic thromboembolic pulmonary disease (CTEPD) and/or Chronic thromboembolic pulmonary hypertension (CTEPH)
時間枠：12 months
12 months
Major bleeding
時間枠：30 days

Major bleeding will be defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria as fatal bleeding, symptomatic bleeding in a critical area or organ, a decrease in hemoglobin of ≥2 g/dL, or transfusion of ≥2 units of whole blood or red blood cells. The number of participants experiencing major bleeding will be recorded
30 days
Clinically relevant non-major bleeding
時間枠：30 days

Clinically relevant non-major bleeding will be defined according to ISTH criteria as bleeding that does not meet the criteria for major bleeding but requires medical intervention, leads to hospitalization or an increased level of care, or prompts a face-to-face evaluation by a healthcare professional. The number of participants experiencing clinically relevant non-major bleeding will be recorded.
30 days
Minor bleeding
時間枠：30 days

Minor bleeding will be defined as any overt bleeding event that does not meet the criteria for major bleeding or clinically relevant non-major bleeding and does not require medical attention. The number of participants experiencing minor bleeding will be recorded.
30 days

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

China National Center for Cardiovascular Diseases

捜査官

  • 主任研究者：Changming Xiong, Prof.、Chinese Academy of Medical Sciences, Fuwai Hospital
  • 主任研究者：Zhenguo Zhai, Prof.、China-Japan Friendship Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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11月1日

一次修了 (推定)

2028年12月31日

研究の完了 (推定)

2029年12月31日

試験登録日

最初に提出

2026年10月15日

QC基準を満たした最初の提出物

2026年11月2日

最初の投稿 (実際)

2026年11月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月4日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年10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

  • 2026ZD0556203-02
  • 2026ZD0556203 (その他の助成金/資金番号：Noncommunicable Chronic Diseases-National Science and Technology Major Project)

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いいえ

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