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Efficacy and Safety of Half Dose Alteplase Added to Heparine, in Patients With Moderate Pulmonary Embolism

NCT02604238 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-02-08

No results posted yet for this study

Summary

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:

* right ventricular dysfunction
* pulmonary hypertension 24 hours and 7 days after the treatment
* PE recurrence to 7days and 30 days after the treatment without increasing the incidence of bleeding intra-extracranial

Conditions

Interventions

DRUG

Alteplase

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).

Sponsors & Collaborators

  • Azienda U.S.L. 1 di Massa e Carrara

    lead OTHER

Principal Investigators

  • Alberto Conti, MD · Azienda USL1 di Massa e Carrara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-03-31
Completion
2016-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02604238 on ClinicalTrials.gov