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Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for Acute Intermediate-Risk Pulmonary Embolism. (PEITHO-2)

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ClinicalTrials.gov Identifier: NCT02596555
Recruitment Status : Recruiting
First Posted : November 4, 2015
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
European Georges Pompidou Hospital
Information provided by (Responsible Party):
Prof. Stavros Konstantinides, MD, Johannes Gutenberg University Mainz

Brief Summary:
This prospective, multicenter, multinational, phase IV, interventional single-armed (management) trial will focus on the safety, efficacy and cost-effectiveness of a new oral anticoagulant in the treatment of patients with acute intermediate-risk PE based on validated imaging (echocardiographic or CT angiographic) and laboratory biomarker (circulating levels of cardiac troponins and natriuretic peptides) parameters and their combinations.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Drug: Dabigatran Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for the Treatment of Acute Intermediate-Risk Pulmonary Embolism
Study Start Date : January 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
Experimental: Dabigatran treatment
Low molecular weight heparin for 72 hours followed by 6 months of dabigatran
Drug: Dabigatran
Low molecular weight heparin for 72 hours followed by 6 months of dabigatran
Other Name: Pradaxa




Primary Outcome Measures :
  1. Occurrence of symptomatic venous thromboembolism (VTE) or pulmonary embolism (PE) related death (yes/no) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Recovery of right ventricle (RV) function [ Time Frame: 6±1 days or upon discharge (whichever comes first), 6 months ]
  2. Temporal pattern of changes in NT-proBNP (N-terminal prohormone of brain natriuretic peptide) levels [ Time Frame: 6±1 days or upon discharge (whichever comes first), 6 months ]
  3. Death from any cause [ Time Frame: 30 days ]
  4. Pulmonary embolism (PE) related death, or PE-related or hemodynamic collapse or decompensation [ Time Frame: 30 days ]
  5. Overall duration of hospital stay [ Time Frame: 6 months ]
  6. Major bleeding [ Time Frame: 6 months ]
  7. Clinically relevant bleeding [ Time Frame: 6 months ]
  8. Serious adverse events (SAE) [ Time Frame: 72 hours, 30 days, 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, with or without symptomatic deep vein thrombosis
  3. Absence of hemodynamic collapse, or decompensation, at presentation; Hemodynamic collapse or decompensation
  4. Intermediate-risk category of PE severity indicated by a positive (score ≥1) simplified pulmonary embolism severity index (sPESI), in combination with the presence of at least one of the following criteria at presentation:

    • At least one sign of RV pressure overload/dysfunction on CT angiography or echocardiography
    • Signs of myocardial injury as indicated by elevated troponin levels
    • Signs of (RV) failure as indicated by NT-proBNP levels >600 pg/ml at baseline.
  5. Ability of the subject to understand the character and individual consequences of the clinical trial; signed and dated informed consent of the subject available before the start of any specific trial procedures

Exclusion Criteria:

  1. Pregnancy (a negative serum or urine pregnancy test should be available for women of child-bearing potential before study inclusion) or lactation
  2. Women of childbearing potential who do not practice a medically accepted highly effective contraception during the trial and one month beyond
  3. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
  4. Participation in another clinical trial during the present clinical trial or within the last three months
  5. Medical or psychological condition that would not permit completion of the trial or signing of informed consent
  6. 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
  7. Treatment with any therapeutically dosed anticoagulant for more than 48 hours prior to enrolment
  8. Need for long-term treatment with a low molecular weight heparin, vitamin K antagonists or NOAC, for an indication other than the index PE episode, or for antiplatelet agents except acetylsalicylic acid at a dosage ≤100 mg/day;
  9. Active bleeding or known significant bleeding risk (e.g., gastrointestinal ulcer, malignant neoplasms, injuries or recent surgeries of the brain, spinal cord or eyes, recent intracranial bleedings, known or suspected esophagus varices, aneurysms or intraspinal or intracranial vascular abnormalities)
  10. Artificial heart valves requiring treatment with an anticoagulant
  11. Renal insufficiency with estimated creatinine clearance <30 ml/min/1.73m2
  12. Chronic liver disease with aminotransferase levels two times or more above the local upper limit of normal range
  13. Concomitant administration of strong inhibitors of P-glycoprotein like ketoconazole, cyclosporin, itraconazole or dronedarone
  14. Unwillingness or inability to adhere to treatment or to the follow-up visits
  15. Life expectancy less than 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596555


Contacts
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Contact: Stavros Konstantinides, Prof., MD +496131178382 stavros.konstantinides@unimedizin-mainz.de
Contact: Kurt Quitzau +496131178252 kurt.quitzau@unimedizin-mainz.de

Locations
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Germany
Center for Thrombosis and Hemostasis, University Medical Center Mainz Recruiting
Mainz, Germany, 55131
Contact: Stavros Konstantinides, Prof., MD    +496131178382    stavros.konstantinides@unimedizin-mainz.de   
Sub-Investigator: Kai-Helge Schmidt, MD         
Sponsors and Collaborators
Prof. Stavros Konstantinides, MD
European Georges Pompidou Hospital
Investigators
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Principal Investigator: Stavros Konstantinides, Prof., MD Center for Thrombosis and Hemostasis, University Medical Center Mainz

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Responsible Party: Prof. Stavros Konstantinides, MD, Medical Director of Center for Thrombosis and Hemostasis, University Medical Center Mainz, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT02596555     History of Changes
Other Study ID Numbers: PEITHO-2
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Dabigatran
Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors