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Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for Acute Intermediate-Risk Pulmonary Embolism.

NCT02596555 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-02-17

No results posted yet for this study

Summary

This prospective, multicenter, multinational, phase IV, interventional single-armed (management) trial will focus on the safety, efficacy and cost-effectiveness of a new oral anticoagulant in the treatment of patients with acute intermediate-risk PE based on validated imaging (echocardiographic or CT angiographic) and laboratory biomarker (circulating levels of cardiac troponins and natriuretic peptides) parameters and their combinations.

Conditions

Interventions

DRUG

Dabigatran

Low molecular weight heparin for 72 hours followed by 6 months of dabigatran

Sponsors & Collaborators

  • European Georges Pompidou Hospital

    collaborator OTHER

  • Prof. Stavros Konstantinides, MD

    lead OTHER

Principal Investigators

  • Stavros Konstantinides, Prof., MD · Center for Thrombosis and Hemostasis, University Medical Center Mainz

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02596555 on ClinicalTrials.gov