Pulmonary EmbolismPhase 3REDUCTIONNCT07917078
Reduced-Dose Thrombolysis in Intermediate-Risk Pulmonary Embolism With High-Risk Features
A Phase 3 study testing Alteplase and Standard Anticoagulation in people with Pulmonary Embolism, run by China National Center for Cardiovascular Diseases at 26 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Alteplase and Standard Anticoagulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 26 sitesChina
- Study dates
- 1 Nov 2026to 31 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Ventilation/perfusion lung scan showing at least one segmental or larger mismatched perfusion defect;
- 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:
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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:
- Known hypersensitivity to alteplase, gentamicin, heparin, low-molecular-weight heparin, or any component of the study treatment;
- Active bleeding or high risk of bleeding;
Show all 36Show fewer
- Known or suspected intracranial hemorrhage;
- Suspected subarachnoid hemorrhage or aneurysmal subarachnoid hemorrhage;
- Significant bleeding disorder within the previous 6 months;
- Known bleeding diathesis;
- Acute ischemic stroke or transient ischemic attack within the previous 6 months;
- Ophthalmic surgery within the previous 3 months, or abdominal, cardiac, thoracic, vascular, or orthopedic surgery or trauma within the previous 3 months;
- History of central nervous system disease or trauma, including tumor, aneurysm, head trauma, intracranial surgery, or spinal surgery;
- Platelet count <100 × 10^9/L;
- International normalized ratio (INR) >1.3;
- Current effective oral anticoagulant treatment;
- Traumatic cardiopulmonary resuscitation;
- Infective endocarditis or pericarditis;
- Acute pancreatitis;
- Noncompressible vascular puncture;
- Severe uncontrolled hypertension, with systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg;
- Any other condition considered by the investigator to confer a high bleeding risk;
- Severe liver disease, including liver failure, cirrhosis, portal hypertension, esophageal varices, or active hepatitis;
- Gastrointestinal ulcer, esophageal varices, arterial aneurysm, or arteriovenous malformation within the previous 3 months;
- Tumor with bleeding tendency;
- Pregnancy or within 1 week postpartum;
- 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.
Trial locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
26 sites in 1 country
China26 sites
Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia, 014010
Hongjun Tian, Prof., 0472-5992811, 1139717960@qq.com
Beijing ChaoYang Hospital.Capital Medical University
Beijing, Beijing Municipality, 100020
Yuanhua Yang, Prof., 010-85231777, yyh1031@sina.com
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Jun Wan, Prof., 010-64412431, blueswan2013@yahoo.com
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Zhenguo Zhai, 010-84205566, zhaizhenguo2011@126.com
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Juhong Shi, Prof., 010-69156114, shijh@pumch.cn
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, 100037
Changming Xiong, Prof., 010-88396798, xiongcmfw@163.com
The Second People's Hospital of Changzhou, The Third Affiliated Hospital of Nanjing Medical University
Changzhou, Jiangsu, 213003
Qian Zhang, Prof., 0519-81099988, kezhang0601@163.com
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Maojun Wang, Prof., 028-85422114, wmmyun@hotmail.com
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120
Yinji Xu, Prof., 020-81887233, xuyinji@163.com
The First Affiliated Hospital of Guangzhou Medical University / Guangzhou Institute of Respiratory Health (National Clinical Research Center for Respiratory Disease)
Guangzhou, Guangdong, 510120
Nuofu Zhang, Prof., 020-83062114, nfzhanggird@163.com
Shandong Provincial Hospital
Jinan, Shandong, 250021
Ling Zhu, Prof., 0531-87938911, zhuling7103@163.com
Linyi People's Hospital
Linyi, Shandong, 276000
Le Kang, Prof., 0539-8616398, 593119267@qq.com
Nanjing First Hospital
Nanjing, Jiangsu, 210006
He Xu, Prof., 025-52271000, hexunj@163.com
Shanghai East Hospital, School of Medicine, Tongji University
Shanghai, Shanghai Municipality, 200120
Yingqun Ji, Prof., 021-38804518, jiyingqun@163.com
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110003
Liang Shi, Prof., 024-28886666, 13309889463@163.com
Central Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning, 110024
Shuyue Xia, Prof., 024-85715200, syx262@126.com
Longgang Central Hospital of Shenzhen
Shenzhen, Guangdong, 518116
Siliang Xu, Prof., 0755-84806933, 420814562@qq.com
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Lixia Dong, Prof., 022-96580, 18355193818@163.COM
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222
Songtao Gu, 022-88185111, gusongtaodoctor@126.com
NMG Keerqin District Hosp.
Tongliao, Inner Mongolia, 028000
Xili Wang, Prof., 0475-8232510, 861004223@qq.com
Wuhan Sixth Hospital (Affiliated Hospital of Jianghan University)
Wuhan, Hubei, 430015
Fajiu Li, Prof., 027-82426502, 80670519@qq.com
HeNan Honliv Hospital
Xinxiang, Henan, 453400
Lei Yang, Prof., 0373-8882288, 61194255@qq.com
Ningxia Medical University General Hospital
Yinchuan, Ningxia, 750004
Juan Chen, Prof., 0951-6744457, chenjuan7419@163.com
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, 075000
Baoli Xiang, Prof., 0313-8043555, 15530396731@163.com
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Yong Qi, Prof., 0371-65580014, srmyy123@163.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Zhe Cheng, Prof., 0371-66913114, chengzhehi@126.com
About this study
Official title: 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.
Read the detailed description
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)
- Conditions
- Pulmonary Embolism
- Being tested
- Alteplase, Standard Anticoagulation
- Keywords
- Acute intermediate-high risk pulmonary embolism, Thrombolysis
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlteplaseDrug
Alteplase 25 mg will be administered by continuous intravenous infusion over 2 hours
Standard AnticoagulationDrug
Standard anticoagulation will consist of LMWH or UFH administered according to current guideline recommendations for at least 5 days
| Study group | Role | What they receive |
|---|---|---|
| Reduced-Dose Alteplase and Standard Anticoagulation | Active comparator | Low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) and reduced-dose alteplase [25 mg continuous intravenous infusion for 2 hours] Receives: Drug: Alteplase; Drug: Standard Anticoagulation |
| Standard Anticoagulation | Active comparator | Low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) Receives: Drug: Standard Anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter (RVED/LVED) as measured by echocardiography
Measured: Between baseline and 48 hours
Secondary outcomes (12)
Change in the ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter (RVED/LVED) as measured by echocardiography
Measured: Between baseline and 7 days
Clinical Deterioration
Measured: 7 days
PE-Related Death
Death caused by pulmonary embolism (PE)
Measured: 7 days
All cause Death
Measured: 7 days
Recurrent PE
Measured: 7 days
Persistent Dyspnea
Persistent Dyspnea Assessed by the Medical Research Council (MRC) Dyspnea Scale
Measured: 6 months
Functional outcome
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.
Measured: 6 months
Persistent Right Ventricular Dysfunction
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.
Measured: 6 months
Chronic thromboembolic pulmonary disease (CTEPD) and/or Chronic thromboembolic pulmonary hypertension (CTEPH)
Measured: 12 months
Major bleeding
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
Measured: 30 days
Clinically relevant non-major bleeding
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.
Measured: 30 days
Minor bleeding
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Changming Xiong, Prof., Principal investigator, Chinese Academy of Medical Sciences, Fuwai HospitalZhenguo Zhai, Prof., Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917078
- Sponsor's protocol ID
- 2026ZD0556203-02
- Other IDs
- 2026ZD0556203
- Acronym
- REDUCTION
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu L, Li C, Shi L, Ma D, Zhang Z, Bao H, Li C, Li L, Wang M, Ma Z, Zhang J. Efficacy and safety of low-dose thrombolysis in acute intermediate-high risk pulmonary thromboembolism complicated by PaO2/FiO2 < 300. Front Med (Lausanne). 2026 Jul 9;13:1849541. doi: 10.3389/fmed.2026.1849541. eCollection 2026.
PubMed 42494448Sanchez O, Charles-Nelson A, Ageno W, Barco S, Binder H, Chatellier G, Duerschmied D, Empen K, Ferreira M, Girard P, Huisman MV, Jimenez D, Katsahian S, Kozak M, Lankeit M, Meneveau N, Pruszczyk P, Petris A, Righini M, Rosenkranz S, Schellong S, Stefanovic B, Verhamme P, de Wit K, Vicaut E, Zirlik A, Konstantinides SV, Meyer G; PEITHO-3 Investigators. Reduced-Dose Intravenous Thrombolysis for Acute Intermediate-High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial. Thromb Haemost. 2022 May;122(5):857-866. doi: 10.1055/a-1653-4699. Epub 2021 Oct 31.
PubMed 34560806Yilmaz ES, Uzun O. Low-dose thrombolysis for submassive pulmonary embolism. J Investig Med. 2021 Dec;69(8):1439-1446. doi: 10.1136/jim-2021-001816. Epub 2021 Jun 7.
PubMed 34099544Zhang LY, Gao BA, Jin Z, Xiang GM, Gong Z, Zhang TT, Lu HF, Wang YQ, Gong Y, Lu C, Huang WL. Clinical efficacy of low dose recombinant tissue-type plasminogen activator for the treatment of acute intermediate-risk pulmonary embolism. Saudi Med J. 2018 Nov;39(11):1090-1095. doi: 10.15537/smj.2018.11.22717.
PubMed 30397707Sharifi M, Bay C, Skrocki L, Rahimi F, Mehdipour M; "MOPETT" Investigators. Moderate pulmonary embolism treated with thrombolysis (from the "MOPETT" Trial). Am J Cardiol. 2013 Jan 15;111(2):273-7. doi: 10.1016/j.amjcard.2012.09.027. Epub 2012 Oct 24.
PubMed 23102885Wang C, Zhai Z, Yang Y, Wu Q, Cheng Z, Liang L, Dai H, Huang K, Lu W, Zhang Z, Cheng X, Shen YH; China Venous Thromboembolism (VTE) Study Group. Efficacy and safety of low dose recombinant tissue-type plasminogen activator for the treatment of acute pulmonary thromboembolism: a randomized, multicenter, controlled trial. Chest. 2010 Feb;137(2):254-62. doi: 10.1378/chest.09-0765. Epub 2009 Sep 9.
PubMed 19741062Meyer G, Vicaut E, Danays T, Agnelli G, Becattini C, Beyer-Westendorf J, Bluhmki E, Bouvaist H, Brenner B, Couturaud F, Dellas C, Empen K, Franca A, Galie N, Geibel A, Goldhaber SZ, Jimenez D, Kozak M, Kupatt C, Kucher N, Lang IM, Lankeit M, Meneveau N, Pacouret G, Palazzini M, Petris A, Pruszczyk P, Rugolotto M, Salvi A, Schellong S, Sebbane M, Sobkowicz B, Stefanovic BS, Thiele H, Torbicki A, Verschuren F, Konstantinides SV; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.
PubMed 24716681
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced-Dose Thrombolysis in Intermediate-High Risk Pulmonary Embolism, a Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07917078
- Acronym / sponsor ID
- REDUCTION / 2026ZD0556203-02
- Conditions
- Pulmonary Embolism
- Keywords
- Acute intermediate-high risk pulmonary embolism, Thrombolysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced-Dose Alteplase and Standard Anticoagulation | Active comparator | Drug: Alteplase, Drug: Standard AnticoagulationLow-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) and reduced-dose alteplase [25 mg continuous intravenous infusion for 2 hours] |
| Standard Anticoagulation | Active comparator | Drug: Standard AnticoagulationLow-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Intermediate-high-risk PTE, with both of the following:
- 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
Key exclusion criteria (36 listed)
- 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:
- Body weight ≤40 kg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlteplaseAlteplase 25 mg will be administered by continuous intravenous infusion over 2 hours | Drug | Reduced-Dose Alteplase and Standard Anticoagulation |
| Standard AnticoagulationStandard anticoagulation will consist of LMWH or UFH administered according to current guideline recommendations for at least 5 days | Drug | Reduced-Dose Alteplase and Standard Anticoagulation, Standard Anticoagulation |
Primary outcome
Change in the ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter (RVED/LVED) as measured by echocardiography
Time frame: Between baseline and 48 hours
12 secondary outcomes
Change in the ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter (RVED/LVED) as measured by echocardiography
Time frame: Between baseline and 7 days
Clinical Deterioration
Time frame: 7 days
PE-Related Death
Time frame: 7 days
All cause Death
Time frame: 7 days
Recurrent PE
Time frame: 7 days
Persistent Dyspnea
Time frame: 6 months
Functional outcome
Time frame: 6 months
Persistent Right Ventricular Dysfunction
Time frame: 6 months
Chronic thromboembolic pulmonary disease (CTEPD) and/or Chronic thromboembolic pulmonary hypertension (CTEPH)
Time frame: 12 months
Major bleeding
Time frame: 30 days
Clinically relevant non-major bleeding
Time frame: 30 days
Minor bleeding
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 42494448Liu L, Li C, Shi L, Ma D, Zhang Z, Bao H, Li C, Li L, Wang M, Ma Z, Zhang J. Efficacy and safety of low-dose thrombolysis in acute intermediate-high risk pulmonary thromboembolism complicated by PaO2/FiO2 < 300. Front Med (Lausanne). 2026 Jul 9;13:1849541. doi: 10.3389/fmed.2026.1849541. eCollection 2026.
- Background: PubMed 34560806Sanchez O, Charles-Nelson A, Ageno W, Barco S, Binder H, Chatellier G, Duerschmied D, Empen K, Ferreira M, Girard P, Huisman MV, Jimenez D, Katsahian S, Kozak M, Lankeit M, Meneveau N, Pruszczyk P, Petris A, Righini M, Rosenkranz S, Schellong S, Stefanovic B, Verhamme P, de Wit K, Vicaut E, Zirlik A, Konstantinides SV, Meyer G; PEITHO-3 Investigators. Reduced-Dose Intravenous Thrombolysis for Acute Intermediate-High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial. Thromb Haemost. 2022 May;122(5):857-866. doi: 10.1055/a-1653-4699. Epub 2021 Oct 31.
- Background: PubMed 34099544Yilmaz ES, Uzun O. Low-dose thrombolysis for submassive pulmonary embolism. J Investig Med. 2021 Dec;69(8):1439-1446. doi: 10.1136/jim-2021-001816. Epub 2021 Jun 7.
- Background: PubMed 30397707Zhang LY, Gao BA, Jin Z, Xiang GM, Gong Z, Zhang TT, Lu HF, Wang YQ, Gong Y, Lu C, Huang WL. Clinical efficacy of low dose recombinant tissue-type plasminogen activator for the treatment of acute intermediate-risk pulmonary embolism. Saudi Med J. 2018 Nov;39(11):1090-1095. doi: 10.15537/smj.2018.11.22717.
- Background: PubMed 23102885Sharifi M, Bay C, Skrocki L, Rahimi F, Mehdipour M; "MOPETT" Investigators. Moderate pulmonary embolism treated with thrombolysis (from the "MOPETT" Trial). Am J Cardiol. 2013 Jan 15;111(2):273-7. doi: 10.1016/j.amjcard.2012.09.027. Epub 2012 Oct 24.
- Background: PubMed 19741062Wang C, Zhai Z, Yang Y, Wu Q, Cheng Z, Liang L, Dai H, Huang K, Lu W, Zhang Z, Cheng X, Shen YH; China Venous Thromboembolism (VTE) Study Group. Efficacy and safety of low dose recombinant tissue-type plasminogen activator for the treatment of acute pulmonary thromboembolism: a randomized, multicenter, controlled trial. Chest. 2010 Feb;137(2):254-62. doi: 10.1378/chest.09-0765. Epub 2009 Sep 9.
- Background: PubMed 24716681Meyer G, Vicaut E, Danays T, Agnelli G, Becattini C, Beyer-Westendorf J, Bluhmki E, Bouvaist H, Brenner B, Couturaud F, Dellas C, Empen K, Franca A, Galie N, Geibel A, Goldhaber SZ, Jimenez D, Kozak M, Kupatt C, Kucher N, Lang IM, Lankeit M, Meneveau N, Pacouret G, Palazzini M, Petris A, Pruszczyk P, Rugolotto M, Salvi A, Schellong S, Sebbane M, Sobkowicz B, Stefanovic BS, Thiele H, Torbicki A, Verschuren F, Konstantinides SV; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Changming Xiong, Prof. principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
Zhenguo Zhai, Prof. principal investigator
China-Japan Friendship Hospital
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alteplase and Standard Anticoagulation in people with Pulmonary Embolism, run by China National Center for Cardiovascular Diseases at 26 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Changming Xiong, Prof. ((+86)010-88396798, xiongcmfw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter (RVED/LVED) as measured by echocardiography (time frame: Between baseline and 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07917078, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.