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

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Acute Intermediate-Risk Pulmonary Embolism; MedDRA version: 19.0Level: HLTClassification code 10037379Term: Pulmonary embolism and thrombosisSystem Organ Class: 100000004866

• Registration Number: EUCTR2015-001830-12-NL
• Lead Sponsor: niversity Medical Center of the Johannes Gutenberg University Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-08
• Last Update Posted: 9 November 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:
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 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

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 the index PE episode; or for antiplatelet agents except a etylsalicylic 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