ALTEPLASE for Acute pulmonary embolism (intermediate-high risk)

Inclusion criteria

• {"criterion_text":"- Age > 18 years and  80 years."}
• {"criterion_text":"- Computed tomography angiography (CTA)-verified proximal PE AND symptom onset < 14 days prior."}
• {"criterion_text":"- Intermediate-high risk PE with a sPESI score ≥ 1 AND RV dysfunction AND an elevated biomarker (hs-troponin or NT-proBNP) level."}
• {"criterion_text":"- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Active clinically significant bleeding."}
• {"criterion_text":"- Participation in another clinical trial."}
• {"criterion_text":"- Any haemorrhagic stroke OR a recent (< 6 months) ischaemic stroke/transient ischaemic attack."}
• {"criterion_text":"- Recent (< 3 months) cranial trauma OR another active intracranial/intraspinal process."}
• {"criterion_text":"- Major surgery within 7 days prior."}
• {"criterion_text":"- Active malignancy OR other severe illness with expected survival < 2 years."}
• {"criterion_text":"- Haemoglobin level < 80 g/L; international normalised ratio > 2.0, platelet count ≤ 100 x 109; creatinine level > 200 μmol/L."}
• {"criterion_text":"- Pregnant or breastfeeding, fertility without previous exclusion of gravidity."}
• {"criterion_text":"- Allergic to thrombolytics or heparin or low-molecular-weight heparin (LMWH), contrast allergy, a history of heparin-induced thrombocytopenia."}
• {"criterion_text":"- Floating thrombi in transit through a patent foramen ovale."}

Primary endpoints

• {"endpoint_text":"- All-cause mortality – [ Time Frame: Within 7 days of randomization ]","definition_or_measurement_approach":"All-cause death occurring within 7 days of randomization (time frame specified)."}
• {"endpoint_text":"- PE recurrence (non-fatal symptomatic and objectively confirmed recurrence of PE by repeated CTA) – [ Time Frame: Within 7 days of randomization ]","definition_or_measurement_approach":"Non-fatal symptomatic recurrence of pulmonary embolism objectively confirmed by repeated CT angiography within 7 days of randomization."}
• {"endpoint_text":"- Cardiorespiratory decompensation or collapse* – [ Time Frame: Within 7 days of randomization ]","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- All individual components of primary endpoint – [ Time Frame: Within 7 days, 30 days, and 12 months ]","definition_or_measurement_approach":"Individual components tracked at specified time points (7 days, 30 days, 12 months)."}
• {"endpoint_text":"- First-line therapy failure** – [ Time Frame: Hospitalization ]","definition_or_measurement_approach":"First-line therapy failure assessed during hospitalization (definition referenced by ** not detailed in record)."}
• {"endpoint_text":"- Ischemic or haemorrhagic stroke [ Time Frame: Within 7 days and 30 days ]","definition_or_measurement_approach":"Occurrence of ischemic or haemorrhagic stroke within 7 and 30 days."}
• {"endpoint_text":"- Serious adverse events – [ Time Frame: Within 12 months ]","definition_or_measurement_approach":"Serious adverse events recorded up to 12 months."}
• {"endpoint_text":"- Duration of hospitalization for the index acute PE event (Time from admission to discharge from hospital) – [ Time Frame: Within 30 days ]","definition_or_measurement_approach":"Measured as time (days) from admission to discharge for the index PE event within 30 days."}
• {"endpoint_text":"- Duration of stay at the intensive, intermediate or coronary care unit during hospitalization for the index acute PE event (Time from admission to discharge from ICU, intermediate, or CCU) – [ Time Frame: Within 30 days ]","definition_or_measurement_approach":"Measured as time (days/hours) spent in ICU/intermediate/CCU during hospitalization for the index event within 30 days."}
• {"endpoint_text":"- Hospitalization cost (cost-effectiveness analysis) – [ Time Frame: Within 30 days ]","definition_or_measurement_approach":"Health economic evaluation of hospitalization costs within 30 days."}
• {"endpoint_text":"- GUSTO major (moderate and severe) bleeding*** – [ Time Frame: Within 30 days ]","definition_or_measurement_approach":"Bleeding classified by GUSTO criteria within 30 days (definition referenced by *** not detailed in record)."}
• {"endpoint_text":"- International Society on Thrombosis and Hemostasis (ISTH) major bleeding**** – [ Time Frame: Within 30 days ]","definition_or_measurement_approach":"Bleeding events classified as ISTH major bleeding within 30 days (definition referenced by **** not detailed in record)."}
• {"endpoint_text":"- All bleeding complications scored by the Bleeding Academic Research Consortium (BARC) classification – [ Time Frame: Within 30 days and 12 months ]","definition_or_measurement_approach":"Bleeding complications scored using BARC classification at 30 days and 12 months."}
• {"endpoint_text":"- Change in the RV-to-LV diameter ratio, systolic pulmonary artery pressure (sPAP), Tricuspid annular plane systolic excursion (TAPSE), Tissue Doppler imaging-derived Tricuspid lateral annular Systolic Velocity (S´ TDI) as measured by echocardiography – [ Time Frame: Between Randomization and 24±3 hours, at 30 days, 12 months and 24 months ]","definition_or_measurement_approach":"Echocardiographic measurements (RV/LV ratio, sPAP, TAPSE, S' TDI) at specified time points including baseline to 24±3 hours, 30 days, 12 and 24 months."}
• {"endpoint_text":"- Functional status as measured by World Health Organization (WHO) functional class***** – [ Time Frame: Discharge, 30 days, 12 months and 24 months ]","definition_or_measurement_approach":"WHO functional class assessed at discharge, 30 days, 12 and 24 months (***** reference not detailed in record)."}
• {"endpoint_text":"- Functional status as measured by 6-Minute Walk Test (6MWT) ****** – [ Time Frame: 12 months and 24 months ]","definition_or_measurement_approach":"6MWT distance measured at 12 and 24 months (****** reference not detailed in record)."}
• {"endpoint_text":"- Quality of life using EQ-5D scale******* – [ Time Frame: 30 days, 12 months and 24 months ]","definition_or_measurement_approach":"EQ-5D questionnaire administered at 30 days, 12 and 24 months (******* reference not detailed in record)."}
• {"endpoint_text":"- Diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) – [ Time Frame: Within 24 months ]","definition_or_measurement_approach":"Diagnosis of CTEPH within 24 months (clinical diagnostic criteria not detailed in record)."}

Czechia

Earliest CTIS Part Ii Submission Date

03-07-2024

Latest Decision Or Authorization Date

12-03-2025

Processing Time Days

252

Number Of Sites

11

Number Of Participants

558

Primary sponsor

Full Name

Fakultni Nemocnice Kralovske Vinohrady

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Czechia