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PEITHO Pulmonary Embolism Thrombolysis Study
This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, April 2008
Sponsors and Collaborators: Assistance Publique - Hôpitaux de Paris
German Federal Ministry of Education and Research
Boehringer Ingelheim Pharmaceuticals
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00639743
  Purpose

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 Intervention Phase
Pulmonary Embolism
Drug: placebo ( group B)
Drug: tenecteplase (group A)
Phase III

MedlinePlus related topics: Blood Thinners Pulmonary Embolism
Drug Information available for: Heparin Tenecteplase
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Clinical composite endpoint of all-cause mortality or haemodynamic collapse within 7 days [ Time Frame: select one ] [ Designated as safety issue: No ]
  • 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: select one ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death within 7 days [ Time Frame: select one ] [ Designated as safety issue: Yes ]
  • Haemodynamic collapse within 7 days [ Time Frame: select one ] [ Designated as safety issue: Yes ]
  • Confirmed symptomatic pulmonary embolism recurrence within 7 days [ Time Frame: select one ] [ Designated as safety issue: Yes ]
  • Death within 30 days [ Time Frame: select one ] [ Designated as safety issue: Yes ]
  • Total strokes (intra cranial haemorrhage or ischaemic stroke) within 7 days [ Time Frame: select one ] [ Designated as safety issue: Yes ]
  • Major bleeding (othe [ Time Frame: select one ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: November 2007
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
tenecteplase (group A)
Drug: tenecteplase (group A)
tenecteplase (group A)
B: Placebo Comparator
placebo ( group B)
Drug: placebo ( group B)
placebo ( group B)

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639743

Contacts
Contact: Guy MEYER, MD PhD +33(0) 1 56 09 34 62 guy.meyer@hegp.aphp.fr
Contact: Philippe GALLULA +33 (0) 1 44 84 17 34 philippe.gallula@sls.aphp.fr

Locations
France
Hopital Europeen George Pompidou Recruiting
PARIS, France, 75015
Contact: Guy MEYER, MD PhD         guy.meyer@hegp.aphp.fr    
Contact: Philippe GALLULA         philippe.gallula@sls.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
German Federal Ministry of Education and Research
Boehringer Ingelheim Pharmaceuticals
Investigators
Principal Investigator: Guy MEYER, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications of Results:
Responsible Party: Department Clinical Research of Developpement ( Philippe GALLULA )
Study ID Numbers: P030444
Study First Received: March 13, 2008
Last Updated: May 26, 2008
ClinicalTrials.gov Identifier: NCT00639743  
Health Authority: United States: Food and Drug Administration

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pulmonary embolism
Heparin
Thrombolytic therapy
Bleeding

Study placed in the following topic categories:
Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism
Lung Diseases
Vascular Diseases
Tenecteplase
Hemorrhage
Heparin
Thrombosis
Calcium heparin

Additional relevant MeSH terms:
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009