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Reduced-Dose vs Full-Dose Alteplase in High-Risk Pulmonary Embolism
NCT07816978Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Dec 2026
- Primary completion
- Jan 2030
- Countries
- 3
- Sponsor
- Sahlgrenska University Hospital
- Conditions
- pulmonary embolism (PE)
01
Overview
Phase 4, randomised, open-label trial of tissue-plasminogen activator in pulmonary embolism (PE) (2 arms), sponsored by Sahlgrenska University Hospital. Primary endpoints: Incidence of composite efficacy endpoint at 7 days and Incidence of severe clinically significant bleeding at 7 days. Planned start Dec 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Reduced-Dose Alteplase
Alteplase 0.6 mg/kg (max 50 mg) IV over 15 minutes
Full-Dose Alteplase
Alteplase 1.5 mg/kg (max 100 mg) IV bolus + infusion over 2 hours
03
Who it enrols
Adults with acute high-risk pulmonary embolism verified by imaging or bedside echo, at high risk for early death, without catastrophic PE, contraindications to thrombolysis, or prior reperfusion treatment.
04
Endpoints
Primary
Incidence of composite efficacy endpoint
Incidence of severe clinically significant bleeding
Secondary
All-cause mortality
Pulmonary embolism-related mortality
Cardiopulmonary resuscitation and/or VA-ECMO
Incidence of clinical deterioration
Lack of clinical improvement assessed by SCAI SHOCK stage and oxygen requirement
Time to clinical stabilization based on predefined hemodynamic and respiratory criteria
Incidence of recurrent pulmonary embolism
Initiation of invasive or non-invasive mechanical ventilation
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