Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism

Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism in Context of Pulmonary Hypertension, Right Heart Failure and Patient Functional Ability

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02132689

Acronym

CONTACT-SPE

Enrollment

100

Registered

2014-05-07

Start date

2011-03-31

Completion date

2015-12-31

Last updated

2018-03-19

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

Conditions

Pulmonary Embolism

Keywords

Moderate Risk Acute Pulmonary Embolism

Brief summary

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.

Detailed 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.

Interventions

DRUGActilyse (Thrombolytic therapy)

DRUGHeparine (Standard anticoagulation therapy)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical manifestations of right ventricular failure and pulmonary hypertension and cardiovascular-related death	12 months	The primary outcome of the study is to follow clinical manifestations of right ventricular failure (assessed according to the New York Heart Association /NYHA/ classification).
Pulmonary hypertension	12 months	The primary outcome of the study is to follow pulmonary hypertension (measured in mmHg).
Cardiovascular-related deaths	12 months	The primary outcome of the study is to follow the number of cardiovascular-related deaths within the time frame of 12 months.

Secondary

Measure	Time frame	Description
Echocardiographic manifestations of right ventricular failure and pulmonary hypertension.	12 months	The secondary outcome measure of the study is to follow echocardiographic manifestations of right ventricular failure (TdiSm).

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026