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

2 listopada 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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)

Typ studiów

Interwencyjne

Zapisy (Szacowany)

270

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Changming Xiong, Prof.
  • Numer telefonu: (+86)010-88396798
  • E-mail: xiongcmfw@163.com

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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]
Lek: Alteplase

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

Lek: Standard Anticoagulation

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

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

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

Co mierzy badanie?

Podstawowe miary wyniku

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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in the ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter (RVED/LVED) as measured by echocardiography
Ramy czasowe: Between baseline and 7 days
Between baseline and 7 days
Clinical Deterioration
Ramy czasowe: 7 days
7 days
PE-Related Death
Ramy czasowe: 7 days

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

Persistent Dyspnea Assessed by the Medical Research Council (MRC) Dyspnea Scale
6 months
Functional outcome
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 12 months
12 months
Major bleeding
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

China National Center for Cardiovascular Diseases

Śledczy

  • Główny śledczy: Changming Xiong, Prof., Chinese Academy of Medical Sciences, Fuwai Hospital
  • Główny śledczy: Zhenguo Zhai, Prof., China-Japan Friendship Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 listopada 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2028

Ukończenie studiów (Szacowany)

31 grudnia 2029

Daty rejestracji na studia

Pierwszy przesłany

15 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 listopada 2026

Pierwszy wysłany (Rzeczywisty)

4 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2026ZD0556203-02
  • 2026ZD0556203 (Inny numer grantu/finansowania: Noncommunicable Chronic Diseases-National Science and Technology Major Project)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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