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NCT Number: NCT06487052

Evaluation of the Standard Catheter-directed Thrombolysis Effectiveness in Intermediate-High-Risk Pulmonary Embolism Patients

A single-center, open-label, randomized comparative study of two treatment strategies in patients with intermediate-high-risk acute pulmonary embolism (PE). Patients will be randomized in a 1:1 ratio to standard anticoagulant therapy or standard catheter-directed thrombolysis (SСDT) with a low dose of alteplase, followed by evaluation of short- and long-term efficacy and safety in each group

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Almazov National Medical Research Centre

Saint Petersburg, 197341, Russia

Location status: Recruiting

Location contact

Alexandra Konradi, MD, PhD

CONTACT

[email protected]

007(812)7023749 ext. 005103

Svetlana Villevalde, MD, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Computed tomography angiography (CTA) - verified proximal (pulmonary trunk and/or main and/or lobar branches of the pulmonary artery) PE and symptom onset < 14 days prior
  • Intermediate-high risk PE with a RV dysfunction (RV/LV diameter ratio >1 on TTE or CTA) and an elevated biomarker (hs-troponin or NT-proBNP) level
  • Signed informed consent

Exclusion criteria

  • High-risk pulmonary embolism
  • Thrombus in the heart chambers on TTE
  • Absolute contraindications for the use of thrombolytic therapy: history of hemorrhagic stroke or stroke of unknown etiology; ischemic stroke or transient ischemic attack within the last 6 months; extensive bleeding currently or within the previous 6 months, hemorrhagic diathesis; diseases of the central nervous system (including neoplasms, aneurysm, surgery on the brain or spinal cord); intracranial (including subarachnoid) hemorrhage currently or in history, suspicion of hemorrhagic stroke; severe uncontrolled arterial hypertension; major surgery or major trauma within the previous 3 months, recent traumatic brain injury; labor during the previous 10 days; severe liver diseases, including liver failure, cirrhosis, portal hypertension (including esophageal varices) and active hepatitis; bacterial endocarditis, pericarditis; acute pancreatitis; confirmed peptic ulcer of the stomach or duodenum within the last 3 months; arterial aneurysms, congenital anomalies of arteries/veins;
  • Haemoglobin level < 70 g/L, platelet count ≤ 100 x 109
  • Allergic to alteplase or UFH or contrast allergy
  • Pregnant or breastfeeding
  • Clinically significant malignancies

Treatment and study plan

Standard Catheter-Directed Low Dose Thrombolysis

Combination Product

Using femoral or jugular vein access the mechanical blood clots fragmentation by PigTail 6F catheter circular rotational movements. For unilateral thromboembolism, the PigTail catheter is positioned in the obstructed branch of the pulmonary artery, 1 mg of alteplase is injected as a bolus, followed by a micro-jet injection of 1 mg/hour. For bilateral thromboembolism, the PigTail catheter is positioned in the pulmonary trunk with a bolus of 2 mg alteplase followed by an infusion of 2 mg/hour. The total duration of infusion will be 9 hours, the total dose of alteplase will be 10 mg for unilateral lesions and 20 mg for bilateral lesions. During the alteplase infusion, unfractionated heparin is continued with a target activated partial thromboplastin time (aPTT) of 50 to 60 seconds. After completion of the procedure, UFH therapy is continued for 24 hours, followed by a change to oral anticoagulants.

Standard anticoagulation

Drug

Therapy with UFH with targeted аPTT lasts for 24 hours (no more than 48 hours in total). Then the change to oral anticoagulants is performed

Primary outcomes

  1. A decrease in the ratio of RV/LV diameters

    Time frame: 48 ± 6 hours

    A decrease in the ratio of RV/LV diameters by 20% or more from the initial value 48 ± 6 hours after initiation of therapy

Secondary outcomes

  1. Mortality

    Time frame: 90 days

    Mortality

  2. Cardiorespiratory decompensation or collapse

    Time frame: 7 days

    necessity of inotropic and vasopressor support; cardiac arrest or need for CPR; obstructive shock, placement on extracorporeal membrane oxygenation (ECMO), intubation, or initiation of non-invasive mechanical ventilation

  3. Major bleeding events

    Time frame: 7 days

    International Society on Thrombosis and Hemostasis (ISTH) major bleeding

  4. PE thrombus load reduction

    Time frame: 48 hours

    Qanadli score by CT-scan

  5. The degree of residual pulmonary artery thrombosis with perfusion deficiency

    Time frame: 180 days

    The degree of residual pulmonary artery thrombosis with perfusion deficiency by CT-scan

  6. Post-pulmonary embolism syndrome formation

    Time frame: 180 days

    The presence of symptomatic pulmonary artery residual thrombosis

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Simakova

CONTACT

[email protected]

+79215898763

Olga Moiseeva

CONTACT

[email protected]

+79213068249

Sponsors and collaborators

Lead sponsor

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Other

Registry information

Official study title

Evaluation of the Standard Catheter-directed Thrombolysis (SCDT) Effectiveness in Intermediate-High-Risk Pulmonary Embolism Patients

Acronym: ESCADlys-PE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 5, 2024
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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