Catheter-directed Thrombolysis in Intermediate-high Risk Acute Pulmonary Embolism
Status:
Not yet recruiting
Trial end date:
2028-01-01
Target enrollment:
Participant gender:
Summary
Background: Intermediate-high risk acute pulmonary embolism (PE) remains associated with
substantial mortality despite standard anticoagulation therapy. Previous efforts to decrease
mortality in these patients via administration of systemic thrombolysis have failed due to an
increased rate of major bleeding complications. Catheter-directed thrombolysis (CDT) has
already shown some promising results in terms of efficacy and safety, including the results
of our randomized pilot study. However, large randomized trials with clinical endpoints
comparing catheter-directed local thrombolysis versus standard anticoagulation therapy are
still lacking, thus the treatment of intermediate-high risk acute PE patients has not changed
for decades. Hypothesis: Catheter-directed local thrombolysis is superior to standard
anticoagulation therapy in the treatment of intermediate-high risk acute pulmonary embolism,
with no additional safety concerns. Statistical considerations: Estimated incidence of the
primary endpoint of 1.5% in the CDT group and 6.0% in the standard anticoagulation group, 80%
power for each arm with a 2-sided alpha of 0.05. Five hundred fifty-eight should provide the
requisite number of events. Statistical Analysis - Intention to Treat. Methods and Results: A
Multicentre, Randomized Trial of Catheter-directed thrombolysis in intermediate-high risk
acute pulmonary embolism (PRAGUE-26) is a noncommercial, multicentre, randomized, controlled
parallel-group comparison trial. The trial plans to include 558 patients with
intermediate-high risk acute PE. Patients will be randomized in a 1:1 ratio to CDT or to
standard anticoagulation therapy. The primary outcome of the study is a clinical composite of
all-cause mortality, PE recurrence or cardiorespiratory decompensation, within 7 days of
randomization. Secondary objectives cover all bleeding complications, functional and
patient-reported outcomes over a follow-up period of 24 months and cost-effectiveness
analysis.
Phase:
Phase 4
Details
Lead Sponsor:
Faculty Hospital Kralovske Vinohrady
Collaborators:
Charles University General University Hospital in Prague Pardubice Hospital St. Anne´s University Hospital Brno University Hospital Brno University Hospital Olomouc University Hospital Ostrava University Hospital Pilsen