Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism (CONTACT-SPE)

University Hospital Ostrava

Status and phase: Completed; Phase 4

Conditions: Pulmonary Embolism

Treatments: Drug: Heparine (Standard anticoagulation therapy); Drug: Actilyse (Thrombolytic therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT02132689

FNO-KVO-3

Details and patient eligibility

About

Currently there is no clear guidance for the treatment of moderate risk of pulmonary embolism. The aim of the study is to compare two different therapeutic modalities - standard anticoagulation versus thrombolytic treatment followed by anticoagulation in standard regimen as stated in the pulmonary embolism guidelines.

Full description

Standard treatment of moderate risk pulmonary embolism constitutes of sole anticoagulation therapy. In case of troponin positivity and/or echocardiographic findings as i.e. thrombi in RV thrombolytic therapy should be considered. The aim of this trial is to compare the two treatment modalities in their ability to reduce/predict 12 month end-point: pulmonary hypertension, right ventricular failure, exercise capacity.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• moderate risk pulmonary embolism as defined by the European Society of Cardiology /ESC/ guidelines
• signed informed consent

Exclusion criteria

• patient not willing to sigh informed consent
• absolute contraindication of thrombolysis
• inability to obtain meaningfull echocardiographic images¨
• pulmonary arterial hypertension
• known right ventricular failure

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Actilyse

Active Comparator group

Description:

Thrombolytic therapy: Patients treated with initial thrombolytic therapy (Actilyse) followed with anticoagulant therapy (unfractionated/low-molecular weight heparin).

Treatment:

Drug: Actilyse (Thrombolytic therapy)

Drug: Heparine (Standard anticoagulation therapy)

UHF/LMWH

Active Comparator group

Description:

Anticoagulation therapy: Patients treated with anticoagulation therapy only (unfractionated/low-molecular weight heparin).

Treatment:

Drug: Heparine (Standard anticoagulation therapy)