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STRATEGY-PE: Real-World Treatment Strategies for Intermediate-High Risk Pulmonary Embolism (STRATEGY-PE)

17. maj 2026 opdateret af: Nanjing First Hospital, Nanjing Medical University

Real-World Comparative Effectiveness and Safety of Anticoagulation, Thrombolysis, and Mechanical Thrombectomy in Intermediate-Risk Acute Pulmonary Embolism: A Multicenter Prospective Cohort Study

This study aims to compare the effectiveness and safety of three treatment strategies (Anticoagulation, Thrombolysis, and Mechanical Thrombectomy) for patients with intermediate-high risk acute pulmonary embolism (PE) in a real-world setting. Approximately 1,300 patients will be enrolled across multiple centers in China. Patients will be followed for 90 days to assess mortality, heart function recovery, bleeding risks, and quality of life. The results will help guide personalized treatment decisions and healthcare policy.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Background: Acute pulmonary embolism (PE) is a severe manifestation of venous thromboembolism (VTE). Intermediate-high risk PE accounts for 20-30% of all PE cases with significant mortality driven by right ventricular (RV) dysfunction. Current guidelines recommend anticoagulation for all, with thrombolysis or mechanical thrombectomy as rescue or alternative therapies. However, there is significant heterogeneity in real-world treatment selection and a lack of head-to-head comparative evidence among the three strategies in complex real-world populations.

Objective: To compare the 30-day and 90-day all-cause mortality and 48-hour RV/LV ratio improvement rate among three treatment strategies (Anticoagulation, Thrombolysis, Mechanical Thrombectomy) in patients with intermediate-high risk acute PE.

Design: This is a prospective, multicenter, non-randomized, pragmatic cohort study. Treatment allocation is based on routine clinical decision-making (natural allocation) without investigator intervention. Advanced statistical methods (Propensity Score Matching/Weighting, Instrumental Variable analysis) will be used to control for confounding factors.

Participants: 1,300 patients with confirmed acute intermediate-high risk PE (RV/LV ratio ≥0.9 and elevated cardiac biomarkers, hemodynamically stable). There are no age limits to reflect real-world diversity.

Interventions/Exposures:

  1. Anticoagulation (AC): Standard anticoagulant therapy (LMWH, DOAC, UFH, or Warfarin).
  2. Thrombolysis (TL): Systemic thrombolysis or Catheter-Directed Thrombolysis (CDT) using agents like Urokinase, Alteplase, etc.
  3. Mechanical Thrombectomy (MT): Mechanical removal of thrombus using FDA/NMPA approved devices (e.g., Indigo, FlowTriever, Acoscream), with or without adjunctive anticoagulation/thrombolysis.

Outcomes:

  • Primary: 30-day and 90-day all-cause mortality; 48-hour RV/LV ratio improvement rate (≥15% reduction).
  • Secondary: Clinical deterioration, major bleeding (ISTH/GUSTO/BARC), functional status (6MWT, NYHA, PVFS), quality of life (PEmb-QoL, EQ-5D-5L), PE recurrence, and healthcare resource utilization.

Follow-up: Patients will be followed at 48 hours, 7 days, 30 days, and 90 days.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

1300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: he xu Dr, doctor
  • Telefonnummer: +86 153 6611 0045
  • E-mail: kilogram@163.com

Studiesteder

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210006
        • Nanjing First Hospital
        • Kontakt:
          • Interventional Vascular Department Director, doctor
          • Telefonnummer: +86-25-52271000
          • E-mail: kilogram@163.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients diagnosed with intermediate-high risk acute pulmonary embolism admitted to participating tertiary hospitals with Pulmonary Embolism Response Teams (PERT).

Beskrivelse

Inclusion Criteria:

  • Age unlimited (reflecting real-world population).
  • Symptom duration of acute PE ≤ 14 days.
  • Confirmed acute PE by CTPA involving main or lobar pulmonary arteries.
  • Defined as Intermediate-High Risk PE meeting all of the following:
  • RV/LV ratio ≥ 0.9 (by CT or Echocardiography).
  • Elevated cardiac biomarkers (Troponin > 99th percentile or BNP > 100 pg/mL).
  • Hemodynamically stable (SBP ≥ 90 mmHg, no vasopressors required).
  • Able to provide informed consent and complete follow-up.

Exclusion Criteria:

  • Already received thrombolysis or mechanical thrombectomy for the current episode prior to enrollment.
  • Unable to obtain baseline or follow-up CTPA imaging.
  • (Note: Unlike strict RCTs, patients with cancer, renal insufficiency, or advanced age are NOT excluded to ensure real-world representativeness).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Anticoagulation Cohort
Patients receiving standard anticoagulation therapy alone without thrombolysis or mechanical thrombectomy.
Medicin: Anticoagulants
Low Molecular Weight Heparin (LMWH), Direct Oral Anticoagulants (DOAC), Unfractionated Heparin (UFH), or Warfarin according to guideline-standard regimens.
Andre navne:
  • Heparin, Enoxaparin, Rivaroxaban, Apixaban, Dabigatran, Edoxaban, Warfarin
Thrombolysis Cohort
Patients receiving systemic thrombolysis or catheter-directed thrombolysis.
Enhed: Mechanical Thrombectomy Devices
Any FDA/NMPA approved mechanical thrombectomy device (e.g., Indigo, FlowTriever, Acoscream) used for clot removal.
Andre navne:
  • Indigo Aspiration System, FlowTriever, Acostream
Mechanical Thrombectomy Cohort
Patients undergoing mechanical thrombectomy procedures using percutaneous devices.
Medicin: Thrombolytic Agents
Urokinase, Pro-urokinase, Alteplase, or Tenecteplase administered systemically or via catheter.
Andre navne:
  • tPA, rt-PA, Urokinase, Tenecteplase

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
All-Cause Mortality at 30 Days
Tidsramme: 30 days
The percentage of participants who die from any cause within 30 days of enrollment.
30 days
All-Cause Mortality at 90 Days
Tidsramme: 90 days
The percentage of participants who die from any cause within 90 days of enrollment.
90 days
Right Ventricular to Left Ventricular (RV/LV) Ratio Improvement Rate at 48 Hours
Tidsramme: 48 hours ± 6 hours
The proportion of participants with a reduction in RV/LV ratio ≥15% from baseline measured by CTPA or Echocardiography.
48 hours ± 6 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Major Bleeding Events
Tidsramme: 48 hours, 7 days, 30 days, 90 days
Incidence of major bleeding defined by ISTH, GUSTO, or BARC criteria (including intracranial hemorrhage).
48 hours, 7 days, 30 days, 90 days
Clinical Deterioration
Tidsramme: 48 hours, 7 days
Composite of hemodynamic instability, need for rescue therapy (escalation to thrombolysis/MT/ECMO), intubation, or PE-related death.
48 hours, 7 days
6-Minute Walk Test (6MWT) Distance
Tidsramme: 30 days, 90 days
Change in walking distance from baseline (estimated) to follow-up. Minimal Clinically Important Difference (MCID) ≥30 meters.
30 days, 90 days
Post-VTE Functional Status (PVFS) Score
Tidsramme: 30 days, 90 days
Assessment of functional limitation due to VTE (Scale 0-5).
30 days, 90 days
Quality of Life (PEmb-QoL)
Tidsramme: 90 days

The questionnaire consists of 9 questions containing 40 items, which are organized into 6 domains:

Frequency of Complaints (FC): Assesses the frequency of respiratory and general symptoms (e.g., dyspnea, chest pain).

Daily Activity Limitations (AL): Measures limitations in performing activities of daily living (ADL).

Work-related Problems (WP): Evaluates difficulties in performing work or school duties.

Social Limitations (SL): Assesses restrictions on social activities. Intensity of Complaints (IC): Measures the severity of pain and breathlessness.

Emotional Complaints (EC): Captures anxiety, frustration, and fear related to the disease.
90 days
Symptomatic PE Recurrence
Tidsramme: 90 days
Confirmed recurrent PE via CTPA or V/Q scan.
90 days
ICU Length of Stay
Tidsramme: From ICU admission to ICU discharge, assessed up to 30 days
Duration of intensive care unit stay during the index hospitalization
From ICU admission to ICU discharge, assessed up to 30 days
Total Hospital Length of Stay
Tidsramme: From hospital admission to hospital discharge, assessed up to 90 days
Duration of index hospitalization from emergency department admission to hospital discharge
From hospital admission to hospital discharge, assessed up to 90 days
Total Medical Costs
Tidsramme: Through 90 days
Direct medical costs incurred during index hospitalization and within 90 days of enrollment, including medications, procedures, and hospitalization
Through 90 days

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Biomarker Improvement (Troponin, BNP, D-Dimer)
Tidsramme: 48 hours, 7 days
Percentage reduction in cardiac biomarkers and D-Dimer levels.
48 hours, 7 days
Daily Step Count
Tidsramme: Continuous monitoring through 90 days
Average daily step count measured by smart band (e.g., Xiaomi/Huawei/Apple Watch) during the 90-day follow-up period. Assessed as a continuous variable (steps/day) and correlated with 6-Minute Walk Test distance and Post-VTE Functional Status score.
Continuous monitoring through 90 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. marts 2028

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

24. marts 2026

Først indsendt, der opfyldte QC-kriterier

17. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. maj 2026

Sidst verificeret

1. juli 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KY20260205-04

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data (IPD) and data dictionaries will be made available to researchers upon reasonable request after the publication of the primary results.

IPD-delingstidsramme

Starting 6 months after publication of the primary results, available for 5 years.

IPD-delingsadgangskriterier

Data will be shared with researchers who provide a methodologically sound proposal and whose use of data is for legitimate research purposes. Requests should be directed to the Principal Investigator.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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