Catheter-directed Thrombolysis in Intermediate-high Risk Acute Pulmonary Embolism

Launched by FACULTY HOSPITAL KRALOVSKE VINOHRADY · Aug 5, 2022

Keywords

ClinConnect Summary

This clinical trial, called PRAGUE-26, is investigating a treatment for patients with intermediate-high risk acute pulmonary embolism (PE), a condition where blood clots block blood flow in the lungs. The study aims to determine if a procedure called catheter-directed thrombolysis (CDT), which uses a catheter to deliver medication directly to the clot, is more effective than standard blood-thinning medications in reducing serious complications like death or worsening heart and lung function. Researchers will enroll 558 patients who are between 18 and 80 years old and have certain risk factors, such as recent symptoms of PE and elevated heart-related biomarkers.

Participants in the trial will be randomly assigned to receive either CDT or standard anticoagulation therapy and will be monitored for up to 24 months. Key factors for eligibility include having a confirmed diagnosis of PE, not having any active bleeding issues, and being able to provide informed consent. Throughout the study, participants can expect regular check-ups and assessments of their health outcomes, including any bleeding complications and overall well-being. This research is important as it could potentially change how doctors treat this serious condition.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age \> 18 years and not over 80 years.
• • 2. Computed tomography angiography (CTA)-verified proximal\* PE AND symptom onset \< 14 days prior.
• • 3. Intermediate-high risk PE with a SPESI score ≥ 1 AND RV dysfunction\*\* AND an elevated biomarker \*\*\* (hs-troponin or NT-proBNP) level.
• • 4. Signed informed consent.
• Exclusion Criteria:
• • 1. Active clinically significant bleeding.
• • 2. Any haemorrhagic stroke OR a recent (\< 6 months) ischaemic stroke/transient ischaemic attack.
• • 3. Recent (\< 3 months) cranial trauma OR another active intracranial/intraspinal process.
• • 4. Major surgery within 7 days prior.
• • 5. Active malignancy OR other severe illness with expected survival \< 2 years.
• • 6. Haemoglobin level \< 80 g/L; international normalised ratio \> 2.0, platelet count ≤ 100 x 109; creatinine level \> 200 µmol/L.
• • 7. Pregnant or breastfeeding, fertility without previous exclusion of gravidity.
• • 8. Allergic to thrombolytics or heparin or low-molecular-weight heparin (LMWH), contrast allergy, a history of heparin-induced thrombocytopenia.
• • 9. Floating thrombi in transit through a patent foramen ovale.
• • 10. Participation in another clinical trial.
• • A perfusion defect in at least one main or one lobar pulmonary artery is evident on CTA.
• • RV/LV ratio ≥ 0.9 on transthoracic echocardiography or CTA. \*\*\* hs-troponin I (TnI) \> 53 ng/L (men) or \> 34 ng/L (women); NT-proBNP level \> 600 pg/mL.
• • SPESI - Simplified Pulmonary Embolism Severity Index.