Tenecteplase Pulmonary Embolism Italian Study

• Status: Terminated
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy and safety of Tenecteplase versus Placebo in normotensive patients with sub-massive Pulmonary Embolism and Right Ventricular Dysfunction (RVD) all receiving unfractionated heparin (UFH)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Of Perugia
• Treatments: Tenecteplase; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• age between 18 and 85;

• symptomatic PE confirmed by: high probability lung scan, or intermediate probability lung scan and objectively confirmed deep vein thrombosis, or spiral CT-scan or pulmonary angiography or TE echocardiography;

• normal blood pressure (SBP >100mmHg);

• RVD at echocardiography (see criteria);

• written informed consent.

Exclusion Criteria:

• absence of RVD at echocardiography;

• shock or hypotension (SBP < 100 mmHg);

• therapeutic heparin (UFH or LMWH) treatment for more than 48 hours prior to randomization;

• administration of thrombolytic agents within the previous 4 days;

• vena cava filter insertion or pulmonary thrombectomy within the previous 4 days

• chronic pulmonary hypertension or severe COPD;

• hypertension defined as blood pressure >180/110 mm Hg (systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg) on a single, reliable measurement during current admission at enrolling site prior to randomisation;

• use of GP IIb/IIIa antagonists within the preceding 7 days;

• significant bleeding disorders either at present or within the past 6 months;

• active peptic ulceration;

• known diabetic haemorrhagic retinopathy or other haemorrhagic ophthalmic conditions;

• known haemorrhagic diathesis;

• known arterial aneurysm and known arterial/venous malformation;

• known neoplasm with increased bleeding risk;

• prolonged cardiopulmonary resuscitation (>10 minutes) in the previous two weeks;

• current oral anticoagulation;

• major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months;

• any known history of stroke or transient ischaemic attack (TIA) or dementia;

• any recent head trauma and any other trauma occurring after onset of the current pulmonary embolism;

• any known history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery);

• known subacute bacterial endocarditis;

• known acute pancreatitis;

• known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension

• (oesophageal varices) and active hepatitis;

• pregnancy or lactation or parturition within the previous 30 days;

• women of childbearing potential must have a negative pregnancy test, or use a medically accepted method of birth control;

• treatment with an investigational drug under another study protocol in the past 7 days;

• previous enrolment in this study;

• known hypersensitivity to Tenecteplase, Alteplase, unfractionated heparin, or to any of the excipients;

• anticipated or obvious problem with vascular access;

• any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated;

• inability to follow protocol requirements