Open, randomised, monosite pilot trial for comparison of thrombolytic efficacy of tenecteplase and alteplase in patients with acute pulmonary embolism

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001070-27-AT

Enrollment

Registered

2005-06-02

Start date

2005-07-07

Completion date

Unknown

Last updated

2016-10-31

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

Conditions

Patients with acute pulmonary embolism and indication for thrombolytic therapy are included in the study

Interventions

Trade Name: Metalyse Product Name: Tenecteplase Pharmaceutical Form: Powder and solvent for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. written Informed Consent 2. Patients older than 18, younger than 80 years 3. proven pulmonary embolism Grosser II-III Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. contraindikation for thrombolytic therapy 2. pregnant or nursing women 3. planned use of thrombolytica due to an extensive venous thrombosis 4. known incompatibility with Alteplase or Tenecteplase 5. hospitalizationof the patient is more than five hors ago

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the efficacy of the tested substances by size reduction of pulmonary embolism respectively size reduction of the venous thrombus and recurrence rate;Secondary Objective: Evaluation of the safety of the tested substances by occurence of SAEs and SUSARs and severe bleeding complications;Primary end point(s): reduction of the size of pulmonary embolism and venous thrombus measured by magnet resonance phlebography	—

Measure

Time frame

Main Objective: Evaluation of the efficacy of the tested substances by size reduction of pulmonary embolism respectively size reduction of the venous thrombus and recurrence rate;Secondary Objective: Evaluation of the safety of the tested substances by occurence of SAEs and SUSARs and severe bleeding complications;Primary end point(s): reduction of the size of pulmonary embolism and venous thrombus measured by magnet resonance phlebography

—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026