Actively Recruiting
Catheter-directed Thrombolysis in Intermediate-high Risk Acute Pulmonary Embolism
Led by Faculty Hospital Kralovske Vinohrady · Updated on 2022-11-08
558
Participants Needed
1
Research Sites
271 weeks
Total Duration
On this page
Sponsors
F
Faculty Hospital Kralovske Vinohrady
Lead Sponsor
C
Charles University, Czech Republic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Catheter-directed Thrombolysis in Intermediate-high Risk Acute Pulmonary Embolism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years and not over 80 years.
- Proximal pulmonary embolism confirmed by computed tomography angiography with symptom onset less than 14 days prior.
- Intermediate-high risk pulmonary embolism defined by SPESI score of 1 or more, right ventricular dysfunction, and elevated biomarkers (hs-troponin or NT-proBNP).
- Signed informed consent indicating willingness to participate.
You will not qualify if you...
- Active clinically significant bleeding.
- History of haemorrhagic stroke or ischemic stroke/transient ischemic attack within the past 6 months.
- Recent cranial trauma or active intracranial or spinal conditions within the past 3 months.
- Major surgery within 7 days before enrollment.
- Active cancer or other severe illness with expected survival less than 2 years.
- Low haemoglobin, high INR, low platelet count, or high creatinine levels beyond specified thresholds.
- Pregnancy, breastfeeding, or fertility without prior exclusion of pregnancy.
- Allergies to thrombolytic drugs, heparin, low-molecular-weight heparin, contrast agents, or history of heparin-induced thrombocytopenia.
- Presence of floating thrombi passing through a patent foramen ovale.
- Participation in another clinical trial.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Kralovske Vinohrady
Prague, Czechia, 100 34
Actively Recruiting
Research Team
J
Jitka Havlikova
CONTACT
E
Erika Eksteinova, Ing.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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