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PEITHO Pulmonary Embolism Thrombolysis Study

NCT00639743 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1005

Last updated 2020-11-09

No results posted yet for this study

Summary

Heparin is the reference therapy for most patients with pulmonary embolism. Some patients with sub-massive pulmonary embolism defined by normal blood pressure and dysfunction of the right ventricle have a higher mortality risk. It has been suggested that thrombolytic treatment, a drug that dissolves blood clots more rapidly, may reduce the mortality in those patients. The studies reported to date were unable to confirm or refute this hypothesis because the number of patients included in those studies is too low. The aim of the study is to compare thrombolytic treatment with heparin (which is the reference therapy for pulmonary embolism) in a large group of patients with sub-massive pulmonary embolism.

Conditions

Interventions

DRUG

placebo ( group B)

placebo ( group B)

DRUG

tenecteplase (group A)

tenecteplase (group A)

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Guy MEYER, MD PhD · Assistance Publique Hopitaux de Paris - Department of pneumology - European Hospital George Pompidou - Paris 15

  • Stavros Konstantinides, MD, PhD · Department of Cardiology and Pulmonolog - Universitaetsmedizin Goettingen - 37099 Goettingen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-16
Primary Completion
2012-07-26
Completion
2014-11-30

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Poland
  • Portugal
  • Slovenia
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00639743 on ClinicalTrials.gov