Status:
TERMINATED
Tenecteplase Pulmonary Embolism Italian Study
Lead Sponsor:
University Of Perugia
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 hepar...
Detailed Description
In patients with major acute PE thrombolysis has been shown to be life saving (22). Recent registries showed the beneficial effect of thrombolysis also in patients with PE not associated with shock or...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2006
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00222651
Start Date
July 1 2004
End Date
July 1 2006
Last Update
May 6 2008
Active Locations (30)
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1
Dipartimento di Cardiologia - Ospedale del Delta
Lagosanto, Ferrara, Italy, 44023
2
Unità Operativa di Cardiologia - Azienda Ospedaliera - Ospedale Civile di Vimercate
Desio, Milano, Italy, 20033
3
Divisione di Cardiologia - Azienda Ospedaliera - Ospedale Civile di Legnano
Legnano, Milano, Italy, 2025
4
Unità Operativa di Cardiologia - Ospedale di Circolo e Fondazione Macchi
Varese, Milano, Italy, 21100