E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient suffering from acute pulmonary embolism presenting with right ventricular dysfunction and tested troponin I or T test |
Pazienti con embolia polmonare acuta che presentano disfunzione atriale destra e con test positivo della troponina I o T |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037377 |
E.1.2 | Term | Pulmonary embolism |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate the clinical benefits of tenecteplase over placebo in normotensive patients with acute pulmonary embolism and right ventricular dysfunction |
Dimostrare il beneficio clinico di tenecteplase rispetto a placebo in pazienti normotesi con embolia polmonare acuta e con evidenza di disfunzione ventricolare destra. |
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E.2.2 | Secondary objectives of the trial |
To assess the safety after administration of tenecteplase in normotensive patients with acute pulmonary embolism and with echocardiographic and laboratory evidence of right ventricular dysfunction |
Valutare il profilo di sicurezza della somministrazione di tenecteplase in pazienti normotesi con embolia polmonare acuta e con evidenza di laboratorio ed ecocardiografica di disfunzione ventricolare destra |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
OTHER SUBSTUDIES: OBSERVATIONAL SUBSTUDY:24-month follow-up: The purpose is to examine whether thrombolysis actually reduces the risk of developing Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
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ALTRI SOTTOSTUDI: SOTTOSTUDIO OSSERVAZIONALE -Follow up a 24 mesi: Lo scopo è quello di esaminare se la trombolisi riduca effettivamente il rischio di sviluppare ipertensione polmonare tromboembolica cronica (CTEPH).
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E.3 | Principal inclusion criteria |
- - Age 18 years or older - Patients suffering from acute pulmonary embolism (first symptoms occurring within 15 days) - right ventricular dysfunction on echocardiography and tested troponin I or T positive |
- 18 anni compiuti - embolia polmonare acuta (primi sintomi verificatisi entro 15 gg) - disfunzione atriale destra confermata da ecocardiografia e con test positivo della troponina I o T. |
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E.4 | Principal exclusion criteria |
- Haemodynamic collapse - Known significant bleeding risk - Administration of thrombolytics agents within the previous 4 days - Uncontrolled hypertension, defined as systolic BP>180 mmHg e/o diastolic BP>110 mmHg at randomisation - Pregnancy or women who does not use a medically accepted method of birth control - Known coagulation disorder |
- Collasso emodinamico - Diatesi emorragica nota - Somministrazione di agenti trombolitici nei 4 giorni precedenti - Ipertensione, definita come pressione sistolica >180 mmHg e/o diastolica > 110mmHg alla randomizzazione - Gravidanza o donne in eta' fertile che non utilizzano un sistema contraccettivo adeguato - Disordini noti della coagulazione |
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical composite endpoint of all-cause mortality or haemodynamic collapse within 7 days |
- endpoint clinico composto: mortalita' (per ogni causa) o collasso emodinamico entro i primi 7 giorni. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
raggiungimento del target di pazienti previsto (1000). Lo studio sara` interrotto prima, se il risultato di una eventuale interym analysis mostrera` senza dubbio l`inutilita` a procedere |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |