Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism

NCT04263038

Pulmonary Embolism Embolism Embolism and Thrombosis +6 more

RECRUITING PHASE4

Efficacy and Safety of Half Dose Alteplase Added to Heparine, in Patients With Moderate Pulmonary Embolism

NCT02604238

Pulmonary Embolism

WITHDRAWN PHASE3

Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets

NCT05627375

Venous Thromboembolic Disease

RECRUITING PHASE3

Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer

NCT03045406

Venous Thromboembolism

COMPLETED PHASE3

STOPping Anticoagulation for Isolated or Incidental Subsegmental Pulmonary Embolism

NCT04727437

Subsegmental Pulmonary Embolism Nos

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Embolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Actilyse

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

Group Type ACTIVE_COMPARATOR

Actilyse (Thrombolytic therapy)

Intervention Type DRUG

Heparine (Standard anticoagulation therapy)

Intervention Type DRUG

UHF/LMWH

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

Group Type ACTIVE_COMPARATOR

Heparine (Standard anticoagulation therapy)

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Actilyse (Thrombolytic therapy)

Intervention Type DRUG

Heparine (Standard anticoagulation therapy)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Actilyse unfractionated/low-molecular weight heparine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No