Acute pulmonary embolism: mortality prediction by the 2014 European Society of Cardiology risk stratification model.
Cecilia Becattini, Giancarlo Agnelli, Mareike Lankeit...
https://pubmed.ncbi.nlm.nih.gov/27174887Actively Recruiting
Phase 4
Age: 18Years - 80Years
All Genders
ID05493163
A Multicentre, Randomized Trial of Catheter-directed Thrombolysis in Intermediate-high Risk Acute Pulmonary Embolism (PRAGUE-26)
Led by Faculty Hospital Kralovske Vinohrady · Updated on 2022-11-08
558
Participants Needed
1
Research Sites
104 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
Researchers are evaluating catheter-directed thrombolysis (CDT) compared to standard anticoagulation therapy for treating intermediate-high risk acute pulmonary embolism (PE). This condition carries significant mortality despite current treatments. Earlier attempts at using systemic thrombolysis have increased bleeding risks, but CDT shows promise in improving heart function and reducing blood clots safely. This trial aims to clarify if CDT is superior in clinical outcomes without added safety concerns. The study randomly assigns 558 patients to either CDT or standard anticoagulation therapy. CDT involves placing catheters in the pulmonary arteries to deliver low-dose Alteplase locally over 9 hours, along with intravenous heparin to maintain blood thinning. The standard group continues therapeutic anticoagulation with heparin or low-molecular-weight heparin, with possible transition to oral anticoagulants. Procedures like catheter placement occur within 3 hours after randomization, and treatment details follow strict protocols. Participants undergo routine evaluations including CT angiography, echocardiography, and laboratory tests. Follow-up visits occur at 30 days, 12 months, and 24 months to assess safety, heart function, patient-reported outcomes, and bleeding events. The main outcome measured within 7 days is a composite of death, PE recurrence, or cardiorespiratory failure. Safety is carefully monitored by a data board with interim analyses planned. The total duration of follow-up is 24 months to assess long-term effects and cost-effectiveness.
CONDITIONS
Brief Title
Catheter-directed Thrombolysis in Intermediate-high Risk Acute Pulmonary Embolism
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age over 18 years and not over 80 years
- Computed tomography angiography (CTA)-verified proximal pulmonary embolism with symptom onset less than 14 days prior
- Intermediate-high risk pulmonary embolism with a SPESI score of 1 or higher, right ventricle dysfunction, and elevated biomarkers (hs-troponin or NT-proBNP)
- Signed informed consent
You will not qualify if you...
- Active clinically significant bleeding
- Any hemorrhagic stroke or recent ischemic stroke/transient ischemic attack within 6 months
- Recent cranial trauma or active intracranial/intraspinal process within 3 months
- Major surgery within 7 days prior
- Active cancer or severe illness with expected survival less than 2 years
- Low hemoglobin (less than 80 g/L), high INR (over 2.0), low platelet count (100 x 10^9 or less), or high creatinine (over 200 �b5mol/L)
- Pregnant or breastfeeding, or fertility without previous exclusion of pregnancy
- Allergic to thrombolytics, heparin, low-molecular-weight heparin, contrast allergy, or history of heparin-induced thrombocytopenia
- Floating thrombi moving through a patent foramen ovale
- Participation in another clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants undergo routine clinical evaluation and standard of care testing including CT angiography, transthoracic echocardiography, and laboratory testing for diagnosis and risk stratification of acute pulmonary embolism.
Treatment
Duration - Up to 9 hours for catheter-directed thrombolysis procedure; anticoagulation therapy continues as per routine care post-procedure.
Participants receive either catheter-directed thrombolysis plus anticoagulation therapy or standard anticoagulation therapy alone.
1 day including randomization and treatment procedure with catheter placement and Alteplase infusion; anticoagulation treatment continues as part of standard care.
Follow-up
Duration - 12 months post-randomization with additional assessments up to 24 months.
Participants are monitored for adverse events and clinical outcomes post-treatment with scheduled outpatient visits.
Outpatient visits at 30 days (±3 days), 12 months (±14 days), and 24 months (±14 days) post-randomization.
Trial Site Locations
Total: 1 location
1
University Hospital Kralovske Vinohrady
Prague, Czechia, 100 34
Actively Recruiting
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Research Team
J
Jitka Havlikova
E
Erika Eksteinova, Ing.
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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Published Research Related To This Trial
Single-bolus tenecteplase plus heparin compared with heparin alone for normotensive patients with acute pulmonary embolism who have evidence of right ventricular dysfunction and myocardial injury: rationale and design of the Pulmonary Embolism Thrombolysis (PEITHO) trial.
Steering Committee
https://pubmed.ncbi.nlm.nih.gov/22172434Fibrinolysis for patients with intermediate-risk pulmonary embolism.
Guy Meyer, Eric Vicaut, Thierry Danays...
https://pubmed.ncbi.nlm.nih.gov/24716681Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry.
William T Kuo, Arjun Banerjee, Paul S Kim...
https://pubmed.ncbi.nlm.nih.gov/25856269A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study.
Gregory Piazza, Benjamin Hohlfelder, Michael R Jaff...
https://pubmed.ncbi.nlm.nih.gov/26315743Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism.
Nils Kucher, Peter Boekstegers, Oliver J Müller...
https://pubmed.ncbi.nlm.nih.gov/24226805A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism: The OPTALYSE PE Trial.
Victor F Tapson, Keith Sterling, Noah Jones...
https://pubmed.ncbi.nlm.nih.gov/30025734Randomized Trial Comparing Standard Versus Ultrasound-Assisted Thrombolysis for Submassive Pulmonary Embolism: The SUNSET sPE Trial.
Efthymios D Avgerinos, Wissam Jaber, Joan Lacomis...
https://pubmed.ncbi.nlm.nih.gov/34167677Ultrasound-assisted catheter directed therapy (CDT) for pulmonary embolism versus standard CDT: Sounds of a cry for data!
Andrew Jp Klein, Mehdi H Shishehbor
https://pubmed.ncbi.nlm.nih.gov/30915915A pilot randomised trial of catheter-directed thrombolysis or standard anticoagulation for patients with intermediate-high risk acute pulmonary embolism.
Josef Kroupa, Michal Buk, Jiri Weichet...
https://pubmed.ncbi.nlm.nih.gov/35620984