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Tenecteplase Pulmonary Embolism Italian Study
A Phase II Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of Single Bolus i.v. Tenecteplase Versus Placebo in Normotensive Patients With Pulmonary Embolism and Right Ventricular Dysfunction
1 other identifier
interventional
180
1 country
30
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 heparin (UFH)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2004
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedMay 6, 2008
April 1, 2008
September 16, 2005
April 29, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinically relevant reduction of RVD
24 hours from Tenecteplase or Placebo injection
Secondary Outcomes (3)
Clinically relevant reduction of RVD; Clinical deterioration requiring escalation of treatment
7 days from Tenecteplase or Placebo
PE recurrence
30 days
Death
30 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Dipartimento di Cardiologia - Ospedale del Delta
Lagosanto, Ferrara, 44023, Italy
Unità Operativa di Cardiologia - Azienda Ospedaliera - Ospedale Civile di Vimercate
Desio, Milano, 20033, Italy
Divisione di Cardiologia - Azienda Ospedaliera - Ospedale Civile di Legnano
Legnano, Milano, 2025, Italy
Unità Operativa di Cardiologia - Ospedale di Circolo e Fondazione Macchi
Varese, Milano, 21100, Italy
Divisione Medica II - Ospedale di Vimercate
Vimercate, Milano, 22059, Italy
Medicina D'Urgenza e Pronto Soccorso - Opsedale Regionale
Ancona, 60020, Italy
Divisione di Cardiologia - Azienda Ospedaliera di Venere -Giovanni XXIII
Bari, 70012, Italy
U.O. di Cardiologia - Ospedale di Bentivoglio
Bologna, 40010, Italy
Medicina d'Urgenza - Policlinico S. Orsola
Bologna, Italy
UTIC - Ospedale Civile di Brescia
Brescia, 25100, Italy
Reparto di Cardiologia - Casa di Cura Poliambulanza - Congregazione Suore Ancelle della Carità
Brescia, 25124, Italy
Medicina D'Urgenza, Cardiologia - Ospedale Civile "San Sebastiano"
Caserta, 81100, Italy
Dipartimento di Emergenza Accettazione - Azienda Ospedaliera Universitaria Careggi
Florence, 50100, Italy
Divisione Medica II - Ospedale Galliera
Genova, 16128, Italy
Dipartimento di Emegernza e Accetazione (DEA) - Az. Ospedale-Università San Martino di Genova
Genova, 16132, Italy
Reparto di Cardiologia - Presidio Ospedaliero Piana di Lucca
Lucca, 55100, Italy
Dipartimento Cuore Polmone - Ospedale Carlo Poma
Mantova, 46100, Italy
Reparto di Cardiologia - Azienda Ospedaliera Fatebenfratelli Oftalmico
Milan, 20121, Italy
Medicina D'Urgenza - Ospedale Maggiore Policlinico
Milan, 20122, Italy
Reparto di Pneumologia - Ospedale San Giuseppe
Milan, 20123, Italy
Unità Operativa di Cardiologia - Ospedale S Carlo Borromeo
Milan, 20153, Italy
Medicina D'Urgenza - Az. Osped. Ospedale Niguarda "Cà Granda"
Milan, 20162, Italy
Medicina Interna II - Azienda Ospedaliera "Maggiore della Carità" di Novara
Novara, 28100, Italy
Department of Internal Medicine - University of Perugia
Perugia, 06129, Italy
Malattie Apparato Respiratorio - Ospedale Cisanello
Pisa, 56124, Italy
Reparto di Angiologia - Arcispedale Santa Maria Nuova
Reggio Emilia, 42100, Italy
Divisione di Cardiologia - Ospedale Civile
Rovigo, 45100, Italy
Divisione di Pneumologia - Ospedale S Maria
Terni, 05100, Italy
Medicina D'Urgenza - Azienda Ospedaliera S. Giovanni Battista "Le Molinette"
Torino, 10100, Italy
Medicina D'Urgenza - Ospedale Cattinara
Trieste, 34100, Italy
Related Publications (1)
Becattini C, Agnelli G, Salvi A, Grifoni S, Pancaldi LG, Enea I, Balsemin F, Campanini M, Ghirarduzzi A, Casazza F; TIPES Study Group. Bolus tenecteplase for right ventricle dysfunction in hemodynamically stable patients with pulmonary embolism. Thromb Res. 2010 Mar;125(3):e82-6. doi: 10.1016/j.thromres.2009.09.017. Epub 2009 Oct 14.
PMID: 19833379DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giancarlo Agnelli, MD
Department of Internal Medicine - University of Perugia
- STUDY DIRECTOR
Cecilia Becattini, MD
Department of Internal Medicine - University of Perugia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
July 1, 2004
Study Completion
July 1, 2006
Last Updated
May 6, 2008
Record last verified: 2008-04