A Phase 3 interventional study of Alteplase in Pulmonary Embolism, sponsored by Azienda U.S.L. 1 di Massa e Carrara. Withdrawn. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-08.
Sponsored by Azienda U.S.L. 1 di Massa e Carrara · Phase 3, Interventional, and Treatment
The primary aim of this study is to evaluate whether mid dose (safe dose) of Alteplase in addition to standard treatment with heparin (LMWH) in patients with pulmonary embolism (PE) at intermediate risk, it is effective to reduce:
The guidelines of the European Society of Cardiology (ESC2014) confirm the indication for pharmacological revascularization with thrombolysis only to cases of pulmonary embolism at high risk and thus hemodynamically unstable (class of recommendation I, level of evidence B), reserving the surgical or interventional procedures to cases where thrombolysis has failed or is contraindicated, while it remains controversial the role of thrombolysis in patients with pulmonary embolism at intermediate risk; the current state, in EP intermediate risk, the standard treatment involves the administration of low molecular weight heparin (LMWH), or fondaparinux (for 5-10 days followed by anticoagulation therapy with vitamin K antagonists) or alternatively the new anticoagulants oral (NAO). Although the results of the study PEITHO, recently published, confirm the indication for thrombolytic therapy for primary reperfusion in patients with embolism pulmonary high risk and provide element of reflection about the incidence of intracranial hemorrhage major, recent studies suggest that the thrombolysis with tPA to reduced dose (about half the dose that used in standard thrombolysis) in addition to anticoagulants (low molecular weight heparin) may reduce pulmonary hypertension (systolic artery pulmonary pressure> 40 mmHg) and the incidence of recurrent PE. In this protocol, based on the study MOPETT and pharmacokinetic data available, it is used a "safe dose" (safe dose reduced) of alteplase which provides a intravenous (iv) bolus loading dose of 10 mg in 1 min, followed by intravenous infusion 40 mg within two hours (for patients weighing \<50 kg loading dose iv bolus of 0.5 mg in 1 min, followed by iv infusion of 40 mg within two hours).
After treatment with alteplase, the heparin therapy will be resumed when aPTT values are less than twice the upper limit of normal; the infusion will be adjusted to maintain aPTT between 50-70 seconds (1.5 to 2.5 times the reference value), and for safety reasons are excluded patients> 65 -70 years (increased risk of bleeding complications related age and comorbidities).
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
Browse Pulmonary Embolism studies →Azienda U.S.L. 1 di Massa e Carrara is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
disfunction Ventricular right confirmed by echocardiogram or TC chest:
myocardial damage confirmed with:
Exclusion Criteria:
Administered a "safe dose" of Alteplase. All patients are treated with low molecular weight heparin ( LMWH ) according to the Guidelines ESC2014 heparin in addition it is administered a "safe dose" of Alteplase.
Drug: Alteplase
All patients are treated with low molecular weight heparin ( LMWH ) according to the Guidelines ESC2014 heparin. It not added any treatment.
Enoxaparin (1mg) 100UI aXa/kg/sc \[LMWH\], 15 -30 minutes prior to administration of intravenous (iv) bolus loading dose of 10 mg in 1 min, followed by iv infusion of 40 mg within two hours (for patients weighing \<50 kg, a loading dose of bolus of 0.5 mg in 1 min, followed by iv infusion of 40 mg in two hours); the infusion will be adjusted to maintain the value of aPTT between 50-70 seconds (1.5 to 2.5 times the reference value).
Also known as: tPA-tissue Plasminigen Activator
Pulmonary hypertension reduction (systolic pulmonary pressure greater or equal to 30 mm Hg)
Pulmonary hypertension reduction documented on echocardiography
Time frame: 24 hour
Incidence of recurrent pulmonary embolism fatal or non fatal
Incidence of recurrent pulmonary embolism fatal or non fatal
Time frame: 7 days
Incidence of hemodynamic shock
Incidence of hemodynamic shock \[defined as: need for cardiopulmonary resuscitation, or SBP \<90 mmHg for a period ≥15 min or reduction SBP ≥40 mm Hg for SBP ≥15 min, with evidence of systemic hypoperfusion (cold extremities, diuresis \<30 mL / h, mental confusion), or need for infusion of amines to maintain adequate organ perfusion and SBP\> 90 mm Hg
Time frame: 24 hour and 30 days
Incidence of hospital death from all causes
Incidence of hospital death from all causes
Time frame: 30days
Bleeding extracranial minor and major
Bleeding extracranial minor and major
Time frame: 24 hour and 30 days
No study locations are listed for this record.
This study is withdrawn, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Azienda U.S.L. 1 di Massa e Carrara