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PEITHO Pulmonary Embolism Thrombolysis Study (PEITHO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00639743
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : November 9, 2020
German Federal Ministry of Education and Research
Boehringer Ingelheim
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Drug: placebo ( group B) Drug: tenecteplase (group A) Phase 3

Detailed Description:
A prospective, randomized, double-blind, placebo-controlled, international, multicentre, parallel-group comparison trial evaluating the efficacy and safety of single i.v. bolus tenecteplase plus standard anticoagulation as compared with standard anticoagulation in normotensive patients with acute pulmonary embolism and with echocardiographic and laboratory evidence of right ventricular dysfunction.Patients suffering from acute pulmonary embolism (first symptoms occurring within 15 days) confirmed by lung scanning or a positive spiral computed tomogram, or a positive pulmonary angiogram, presenting with right ventricular dysfunction on echocardiography and tested troponin I or T positive will be included in the study if they have no exclusion criteria.Patients in the investigational group will receive: Ø Tenecteplase as a single body-weight (known or estimated) adjusted IV bolus administered over 5 - 10 seconds not later than 30 minutes after randomization, and not later than 2 hours after the diagnosis of RV dysfunction Weight (kg) Dose in mg Dose in units Dose in ml<60 30 mg 6000 U 6 ml>60 to <70 35 mg 7000 U 7 ml>70 to <80 40 mg 8000 U 8 ml>80 to <90 45 mg 9000 U 9 ml>90 50 mg 10000 U 10 mlØ and: concomitant therapy-Unfractionated heparin at a dose of 80 IUxKg-1 as an intravenous bolus, followed by an infusion of 18 IUxKg-1xh-1, to be administered immediately after randomization in all patients for at least 48 hours following randomization. Beyond this period, intravenous UFH may be substituted with subcutaneous heparin (LMWH) treatment. The bolus will be omitted when heparin was started before randomisation.Patients in the control group will receive Ø placebo as a single body-weight (known or estimated) adjusted IV bolus administered over 5 - 10 seconds not later than 30 minutes after randomization, and not later than 2 hours after the diagnosis of RV dysfunction. Weight (kg) Dose in ml<60 6 ml>60 to <70 7 ml>70 to <80 8 ml>80 to <90 9 ml>90 10 mlØ and concomitant therapy with Unfractionated heparin

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1005 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison Trial Evaluating Efficacy and Safety of Single i.v. Bolus Tenecteplase Plus Standard Anticoagulation as Compared With Standard Anticoagulation in Normotensive Patients
Actual Study Start Date : November 16, 2007
Actual Primary Completion Date : July 26, 2012
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: group A
tenecteplase (group A)
Drug: tenecteplase (group A)
tenecteplase (group A)

Placebo Comparator: group B
placebo ( group B)
Drug: placebo ( group B)
placebo ( group B)

Primary Outcome Measures :
  1. Clinical composite endpoint of all-cause mortality or haemodynamic collapse within 7 days [ Time Frame: Day 7 ]
  2. Haemodynamic collapse is defined as: need for cardiopulmonary resuscitation; or systolic blood pressure < 90 mm Hg for at least 15 min or drop of syst [ Time Frame: Day 7 ]

Secondary Outcome Measures :
  1. Death within 7 days [ Time Frame: Day 7 ]
  2. Haemodynamic collapse within 7 days [ Time Frame: Day 7 ]
  3. Confirmed symptomatic pulmonary embolism recurrence within 7 days [ Time Frame: Day 7 ]
  4. Death within 30 days [ Time Frame: Day 30 ]
  5. Total strokes (intra cranial haemorrhage or ischaemic stroke) within 7 days [ Time Frame: Day 7 ]
  6. Major bleeding (other intracranial haemorrhage or ischaemic stroke) [ Time Frame: Day 7 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 years or older
  • Acute PE (first symptoms occurring 15 days or less before randomisation) confirmed by lung scan, or a positive spiral computed tomogram, or a positive pulmonary angiogram
  • Right ventricular dysfunction confirmed by echocardiography or spiral computed tomography of the chest and a positive troponin I or T test

Exclusion criteria:

  • Haemodynamic collapse at presentation as defined above
  • Known significant bleeding risk
  • Administration of thrombolytic agents within the previous 4 days
  • Vena cava filter insertion or pulmonary thrombectomy within the previous 4 days
  • Uncontrolled hypertension defined as systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg at randomisation
  • Treatment with an investigational drug under another study protocol in the previous 7 days or greater, according to local requirements
  • Previous enrolment in this study
  • Known hypersensitivity to tenecteplase, alteplase, unfractionated heparin, or to any of the excipients
  • Pregnancy, lactation or parturition within the previous 30 days. Women of childbearing age must have a negative pregnancy test or use a medically accepted method of birth control
  • Known coagulation disorder (including vitamin K antagonists)
  • Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639743

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Vienna Medical University
Vienne, Austria
Hospital St. Luc
Brussels, Belgium
CHU Hopital Jean Minjoz
Besançon, France
Freiburg, Germany
Democritus University of Thrace
Alexandroupolis, Greece
University of Pécs
Pécs, Hungary
Rambam Health Care Campus
Haifa, Israel
Istituto di Cardiologia, Policlinico S.Orsola-MaBologna
Bologna, Italy
Medical University of Warsaw
Warsaw, Poland
Hospital Garcia de Orta
Almada, Portugal
University Medical Center
Ljubljana, Slovenia
Ramon y Cajal Hospital
Madrid, Spain
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
German Federal Ministry of Education and Research
Boehringer Ingelheim
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Principal Investigator: Guy MEYER, MD PhD Assistance Publique Hopitaux de Paris - Department of pneumology - European Hospital George Pompidou - Paris 15
Principal Investigator: Stavros Konstantinides, MD, PhD Department of Cardiology and Pulmonolog - Universitaetsmedizin Goettingen - 37099 Goettingen, Germany
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00639743    
Other Study ID Numbers: P030444
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pulmonary embolism
Thrombolytic therapy
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action