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

17. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

1300

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

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

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
All-Cause Mortality at 30 Days
Zeitfenster: 30 days
The percentage of participants who die from any cause within 30 days of enrollment.
30 days
All-Cause Mortality at 90 Days
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Major Bleeding Events
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 30 days, 90 days
Assessment of functional limitation due to VTE (Scale 0-5).
30 days, 90 days
Quality of Life (PEmb-QoL)
Zeitfenster: 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
Zeitfenster: 90 days
Confirmed recurrent PE via CTPA or V/Q scan.
90 days
ICU Length of Stay
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Through 90 days
Direct medical costs incurred during index hospitalization and within 90 days of enrollment, including medications, procedures, and hospitalization
Through 90 days

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Biomarker Improvement (Troponin, BNP, D-Dimer)
Zeitfenster: 48 hours, 7 days
Percentage reduction in cardiac biomarkers and D-Dimer levels.
48 hours, 7 days
Daily Step Count
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. März 2028

Studienabschluss (Geschätzt)

31. Dezember 2029

Studienanmeldedaten

Zuerst eingereicht

24. März 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Mai 2026

Zuerst gepostet (Tatsächlich)

22. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. Mai 2026

Zuletzt verifiziert

1. Juli 2025

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • KY20260205-04

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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