Treatment for Intermediate-High Risk Acute Pulmonary Embolism

A Multicentre, Randomized Trial of Catheter-directed Thrombolysis in Intermediate-high Risk Acute Pulmonary Embolism (PRAGUE-26)

This study tests whether a new treatment using a catheter to break up blood clots can help people with serious pulmonary embolism feel better and live longer compared to standard blood thinners.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 558 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Faculty Hospital Kralovske Vinohrady (Government)
• Locations: 1 site (Prague)
• Trial ID: NCT05493163 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of catheter-directed thrombolysis (CDT) compared to standard anticoagulation therapy in patients with intermediate-high risk acute pulmonary embolism (PE). The study aims to determine if CDT can reduce mortality and improve patient outcomes without increasing the risk of major bleeding complications. Participants will be monitored for improvements in right ventricle function and other clinical endpoints. The trial includes patients aged 18 to 80 with confirmed proximal PE and specific risk factors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with confirmed proximal pulmonary embolism and specific risk factors indicating intermediate-high risk.

Not a fit: Patients with active bleeding, recent strokes, or severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce mortality rates in patients with intermediate-high risk acute pulmonary embolism.

How similar studies have performed: Previous studies have shown promising results for catheter-directed thrombolysis, but large randomized trials comparing it to standard therapy are still lacking.

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.

Where this trial is running

Prague

• University Hospital Kralovske Vinohrady — Prague, Czechia (Recruiting)

Study contacts

• Principal investigator: Viktor Kocka, MD, PhD — Deputy Head of Department of Cardiology
• Study coordinator: Jitka Havlikova

Conditions Pulmonary Embolism; Acute Pulmonary Embolism; Local Thrombolysis; Catheter-Directed Thrombolysis; Intermediate-High Risk