Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222651
Status:
TERMINATED
Last Update Posted:
2008-05-06
First Post:
2005-09-16
Brief Title:
Tenecteplase Pulmonary Embolism Italian Study
Sponsor:
University Of Perugia
Organization:
University Of Perugia
Study Overview
Official Title:
A Phase II Multicenter Randomized Double Blind Study Comparing the Efficacy and Safety of Single Bolus iv Tenecteplase Versus Placebo in Normotensive Patients With Pulmonary Embolism and Right Ventricular Dysfunction
Status:
TERMINATED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
competitor study about to start
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 hypotension 4-23 In these patients thrombolytic treatment has been shown to obtain an improvement of 37 in lung perfusion detected by lung scan with respect to an improvement of 188 obtained by heparin treatment 24 In a different trial rt-PA resulted in a faster and greater improvement of pulmonary artery hypertension than heparin treatment 25 Indeed PE has a wide spectrum of severity at presentation and it is conceivable that the use of more aggressive treatments should be reserved to patients at high risk for adverse outcome Hence the search started of prognostic factors of adverse outcome in patients with pulmonary embolism
RVD has been associated with early adverse outcome PE recurrence and mortality in patients with acute PE 26-28 3 In-hospital mortality in PE patients with and without echocardiographic RVD has been found to be 184 and 57 respectively 3 Ribeiro et al found a higher mortality in patients with PE and severe RVD in-hospital mortality was 79 in the overall population with respect to 143 in patients with severe RVD 5 The ICOPER registry reported a 2-week mortality of 159 in patients presenting with RVD in comparison with 8 in patients without RVD 23 In MAPPET 10 of patients with RVD died within 30 days as compared to 41 of patients without 4
RVD is a common finding in patients with acute PE and normal blood pressure BP 29-33 Recent data suggest that patients with objectively confirmed PE normal BP and echocardiographic evidence of RVD have a high incidence of adverse outcome 7 and may potentially benefit from more aggressive treatment 34-35 In a recent study patients with acute PE were classified according to the presence of RVD and hypotension the short-term mortality and the incidence of PE-related shock in patients with normal BP and echo RVD was respectively 5 and 10 None of the patients with normal BP and no RVD died or experienced PE-related shock 6
It has been recently demonstrated in patients with PE and pulmonary hypertension or RVD but without arterial hypotension or shock that rt-PA significantly reduces the incidence of adverse in-hospital outcome events death and clinical deterioration with respect to heparin 8
Consecutive patients with symptomatic PE since no more than four days confirmed by objective testing high probability lung scan or intermediate probability lung scan and objectively confirmed deep vein thrombosis or spiral CT or pulmonary angiography or TE echocardiography will undergo echocardiographic examination within 24 hour from diagnosis Patients with RVD and normal BP Systolic BP 100 mmHg will be included in the study
180 patients will be randomized in the study The patients included in the study will be randomized in a double blind fashion to receive Tenecteplase UFH 90 patients or Placebo UFH 90 patients
Study treatment should be administered within 6 hours from echocardiography Echocardiography will be repeated at 24 hours and 7 days or discharge whichever comes first from Tenecteplase or Placebo injection A Follow-up visit at 30 days from randomization will include clinical history physical examination and ECG and an echocardiographic examination
RVD has been associated with early adverse outcome PE recurrence and mortality in patients with acute PE 26-28 3 In-hospital mortality in PE patients with and without echocardiographic RVD has been found to be 184 and 57 respectively 3 Ribeiro et al found a higher mortality in patients with PE and severe RVD in-hospital mortality was 79 in the overall population with respect to 143 in patients with severe RVD 5 The ICOPER registry reported a 2-week mortality of 159 in patients presenting with RVD in comparison with 8 in patients without RVD 23 In MAPPET 10 of patients with RVD died within 30 days as compared to 41 of patients without 4
RVD is a common finding in patients with acute PE and normal blood pressure BP 29-33 Recent data suggest that patients with objectively confirmed PE normal BP and echocardiographic evidence of RVD have a high incidence of adverse outcome 7 and may potentially benefit from more aggressive treatment 34-35 In a recent study patients with acute PE were classified according to the presence of RVD and hypotension the short-term mortality and the incidence of PE-related shock in patients with normal BP and echo RVD was respectively 5 and 10 None of the patients with normal BP and no RVD died or experienced PE-related shock 6
It has been recently demonstrated in patients with PE and pulmonary hypertension or RVD but without arterial hypotension or shock that rt-PA significantly reduces the incidence of adverse in-hospital outcome events death and clinical deterioration with respect to heparin 8
Consecutive patients with symptomatic PE since no more than four days confirmed by objective testing high probability lung scan or intermediate probability lung scan and objectively confirmed deep vein thrombosis or spiral CT or pulmonary angiography or TE echocardiography will undergo echocardiographic examination within 24 hour from diagnosis Patients with RVD and normal BP Systolic BP 100 mmHg will be included in the study
180 patients will be randomized in the study The patients included in the study will be randomized in a double blind fashion to receive Tenecteplase UFH 90 patients or Placebo UFH 90 patients
Study treatment should be administered within 6 hours from echocardiography Echocardiography will be repeated at 24 hours and 7 days or discharge whichever comes first from Tenecteplase or Placebo injection A Follow-up visit at 30 days from randomization will include clinical history physical examination and ECG and an echocardiographic examination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None