Safety and Efficacy of Heparin for 72 Hours Followed by Dabigatran for the Treatment of Acute Pulmonary Embolism.

Phase 1

• Conditions: acute intermediate-risk of pulmonary embolism; MedDRA version: 20.0Level: LLTClassification code 10014521Term: Embolism pulmonarySystem Organ Class: 100000015973; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-001830-12-FR
• Lead Sponsor: JOHANNES GUTENBERG UNIVERSITY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-05
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

1)Age ?18 years;
2)Objectively confirmed diagnosis of acute PE by multidetector CT angiography, ventilation/perfusion lung scan, or selective invasive pulmonary angiography, according to established diagnostic criteria;
3)Absence of hemodynamic collapse/decompensation at presentation;
4)Intermediate-risk category of PE severity indicated by the presence of at least one of the following a, b, or c criteria:
a)At least one sign of RV pressure overload/dysfunction on CT angiography or echocardiography (8,23):
a1) on CT angiography, RV pressure overload/dysfunction is defined as RV/LV end-diastolic diameter ratio >1.0; or
a2) on echocardiography, RV pressure overload/dysfunction is defined by the presence of at least one of the following findings:
RV/LV end?diastolic diameter ratio >1.0 (apical or subcostal 4?chamber view);
RV end?diastolic diameter >30 mm (parasternal long?axis or short?axis view);
RV free wall hypokinesis (any view);
Tricuspid regurgitant jet velocity >2.6 m/s from the apical or subcostal 4?chamber view, or the parasternal short?axis view;
Absence of inspiratory collapse of the inferior vena cava.
b)Signs of myocardial injury as indicated by elevated troponin levels:
Troponin elevation is defined as an abnormal result of any validated troponin test based on the reference values determined by the local Department of Clinical Chemistry at each participating site;
c)Signs of (RV) failure as indicated by NT-proBNP levels >600 pg/ml
5)Signed and dated informed consent of the subject available.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1)Pregnancy or women of childbearing potential who do not practice a medically accepted highly effective contraception during the trial and one month beyond;
2)Use of a fibrinolytic agent, surgical thrombectomy, interventional (catheter-directed) thrombus aspiration or lysis, or use of a cava filter to treat the index episode of PE;
3)Need for long-term treatment with a low molecular weight heparin, a vitamin K antagonists, or a new oral anticoagulant (rivaroxaban, dabigatran, apixaban or edoxaban), for an indication other than VTE; or for antiplatelet agents except acetylsalicylic acid at a dosage ?100 mg/day;
4)Active bleeding or known significant bleeding risk;
5)Renal insufficiency with estimated creatinine clearance <30 ml/min/1.73m2;
6)Non-compliance or inability to adhere to treatment or to the follow-up visits;
7)Life expectancy less than 6 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified