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PEITHO-3 - A reduced dose of thrombolytic treatment for patients with intermediate high-risk acute pulmonary embolism: a randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511321-54-00
Acronym
P160924
Enrollment
760
Registered
2024-06-17
Start date
2021-08-04
Completion date
Unknown
Last updated
2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intermediate-high-risk acute pulmonary embolism

Brief summary

The primary outcome is the composite of (1) death from any cause, or (2) hemodynamic decompensation, or (3) objectively confirmed recurrent PE at day 30.

Detailed description

Fatal or GUSTO severe or life-threatening bleeding within 30 days, Net clinical benefit defined as the composite of the primary efficacy outcome and GUSTO severe or life-threatening bleeding within 30 days, All-cause mortality within 30 days

Interventions

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary outcome is the composite of (1) death from any cause, or (2) hemodynamic decompensation, or (3) objectively confirmed recurrent PE at day 30.

Secondary

MeasureTime frame
Fatal or GUSTO severe or life-threatening bleeding within 30 days, Net clinical benefit defined as the composite of the primary efficacy outcome and GUSTO severe or life-threatening bleeding within 30 days, All-cause mortality within 30 days

Countries

Austria, France, Germany, Italy, Netherlands, Poland, Slovenia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026