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Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris German Federal Ministry of Education and Research Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00639743 |
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 |
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Pulmonary Embolism |
Drug: placebo ( group B) Drug: tenecteplase (group A) |
Phase III |
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 |
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 |
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A: Experimental
tenecteplase (group A)
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Drug: tenecteplase (group A)
tenecteplase (group A)
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B: Placebo Comparator
placebo ( group B)
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Drug: placebo ( group B)
placebo ( group B)
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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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
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 |
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 |
Principal Investigator: | Guy MEYER, MD PhD | Assistance Publique - Hôpitaux de Paris |
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 |
Pulmonary embolism Heparin Thrombolytic therapy Bleeding |
Embolism and Thrombosis Pulmonary Embolism Respiratory Tract Diseases Embolism Lung Diseases Vascular Diseases |
Tenecteplase Hemorrhage Heparin Thrombosis Calcium heparin |
Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |