Pulmonary Embolism Clinical Trial
— PEITHOOfficial title:
Comparison Trial Evaluating Efficacy and Safety of Single i.v. Bolus Tenecteplase Plus Standard Anticoagulation as Compared With Standard Anticoagulation in Normotensive Patients
Verified date | November 2020 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1005 |
Est. completion date | November 2014 |
Est. primary completion date | July 26, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Vienna Medical University | Vienne | |
Belgium | Hospital St. Luc | Brussels | |
France | CHU Hopital Jean Minjoz | Besançon | |
Germany | Universistaetsklinik | Freiburg | |
Greece | Democritus University of Thrace | Alexandroupolis | |
Hungary | University of Pécs | Pécs | |
Israel | Rambam Health Care Campus | Haifa | |
Italy | Istituto di Cardiologia, Policlinico S.Orsola-MaBologna | Bologna | |
Poland | Medical University of Warsaw | Warsaw | |
Portugal | Hospital Garcia de Orta | Almada | |
Slovenia | University Medical Center | Ljubljana | |
Spain | Ramon y Cajal Hospital | Madrid |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Boehringer Ingelheim, German Federal Ministry of Education and Research |
Austria, Belgium, France, Germany, Greece, Hungary, Israel, Italy, Poland, Portugal, Slovenia, Spain,
Wan S, Quinlan DJ, Agnelli G, Eikelboom JW. Thrombolysis compared with heparin for the initial treatment of pulmonary embolism: a meta-analysis of the randomized controlled trials. Circulation. 2004 Aug 10;110(6):744-9. Epub 2004 Jul 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical composite endpoint of all-cause mortality or haemodynamic collapse within 7 days | Day 7 | ||
Primary | 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 | Day 7 | ||
Secondary | Death within 7 days | Day 7 | ||
Secondary | Haemodynamic collapse within 7 days | Day 7 | ||
Secondary | Confirmed symptomatic pulmonary embolism recurrence within 7 days | Day 7 | ||
Secondary | Death within 30 days | Day 30 | ||
Secondary | Total strokes (intra cranial haemorrhage or ischaemic stroke) within 7 days | Day 7 | ||
Secondary | Major bleeding (other intracranial haemorrhage or ischaemic stroke) | Day 7 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05050617 -
Point-of-Care Ultrasound in Predicting Adverse Outcomes in Emergency Department Patients With Acute Pulmonary Embolism
|
||
Terminated |
NCT04558125 -
Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism
|
Phase 4 | |
Not yet recruiting |
NCT06017271 -
Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
|
||
Completed |
NCT03915925 -
Short-term Clinical Deterioration After Acute Pulmonary Embolism
|
||
Completed |
NCT02502396 -
Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
|
||
Recruiting |
NCT05171075 -
A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
|
Phase 3 | |
Completed |
NCT04454554 -
Prevalence of Pulmonary Embolism in Patients With Dyspnea on Exertion (PEDIS)
|
||
Completed |
NCT03173066 -
Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography
|
Phase 1 | |
Terminated |
NCT03002467 -
Impact Analysis of Prognostic Stratification for Pulmonary Embolism
|
N/A | |
Completed |
NCT02334007 -
Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery
|
Phase 1/Phase 2 | |
Completed |
NCT02611115 -
Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography.
|
N/A | |
Completed |
NCT01975090 -
The SENTRY Clinical Study
|
N/A | |
Not yet recruiting |
NCT01357941 -
Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE)
|
N/A | |
Completed |
NCT01326507 -
Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism
|
N/A | |
Completed |
NCT00780767 -
Angiojet Rheolytic Thrombectomy in Case of Massive Pulmonary Embolism
|
Phase 2 | |
Completed |
NCT00720915 -
D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months
|
N/A | |
Completed |
NCT00771303 -
Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
|
||
Completed |
NCT02476526 -
Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease
|
Phase 4 | |
Completed |
NCT00773448 -
Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism
|
N/A | |
Completed |
NCT00816920 -
Natural History of Isolated Deep Vein Thrombosis of the Calf
|