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    Summary
    EudraCT Number:2015-001830-12
    Sponsor's Protocol Code Number:CTHC007
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-20
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2015-001830-12
    A.3Full title of the trial
    Safety and Efficacy of Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for the Treatment of Acute Intermediate-Risk Pulmonary Embolism.
    Sicherheit und Effektivität von niedermolekularem Heparin über mindestens 72 Stunden gefolgt von Dabigatran zur Behandlung der akuten Lungenembolie mit intermediärem Risiko.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Heparin for 72 Hours Followed by Dabigatran for the Treatment of Acute Pulmonary Embolism.
    Sicherheit und Effektivität von Heparin über mindestens 72 Stunden gefolgt von Dabigatran zur Behandlung der akuten Lungenembolie.
    A.3.2Name or abbreviated title of the trial where available
    PEITHO-2
    A.4.1Sponsor's protocol code numberCTHC007
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Medical Center of the Johannes Gutenberg University Mainz
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBoehringer Ingelheim
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center of the Johannes Gutenberg University Mainz
    B.5.2Functional name of contact pointCenter for Thrombosis & Hemostasis
    B.5.3 Address:
    B.5.3.1Street AddressLangenbeckstr. 1
    B.5.3.2Town/ cityMainz
    B.5.3.3Post codeD-55131
    B.5.3.4CountryGermany
    B.5.4Telephone number+496131178382
    B.5.5Fax number+496131178461
    B.5.6E-mailstavros.konstantinides@unimedizin-mainz.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Pradaxa 110 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePradaxa 110 mg Hartkapseln
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDABIGATRAN
    D.3.9.1CAS number 211914-51-1
    D.3.9.4EV Substance CodeSUB25417
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Pradaxa 150 mg Hartkapseln
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePradaxa 150 mg Hartkapseln
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDABIGATRAN
    D.3.9.1CAS number 211914-51-1
    D.3.9.4EV Substance CodeSUB25417
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Intermediate-Risk Pulmonary Embolism
    Akute Lungenembolie mit intermediärem Risiko
    E.1.1.1Medical condition in easily understood language
    Acute Pulmonary Embolism
    Akute Lungenembolie
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10037379
    E.1.2Term Pulmonary embolism and thrombosis
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine whether treatment of acute intermediate-risk PE (as defined by the inclusion and exclusion criteria) with parenteral anticoagulation for at least 72 hours after diagnosis, followed by dabigatran over 6 months, is effective and safe.
    Das primäre Ziel besteht in der Feststellung, ob die Behandlung der akuten LE mit intermediärem Risiko (nach der Definition der Einschluss- und Ausschluss-kriterien) mit einer parenteralen Antikoagulation über mindestens 72 Stunden nach Diagnosestellung, gefolgt von Dabigatran über 6 Monate, effektiv und sicher ist.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the recovery of right ventricular function over the first 6±1 days after the PE diagnosis, or upon discharge, and to evaluate its importance for the 6-month prognosis of patients with intermediate-risk PE.
    Das sekundäre Ziel besteht darin zu beurteilen, ob sich die Funktion des rechten Ventrikels während der ersten 6±1 Tage nach der Diagnose einer LE oder bei Entlassung erholt, und welche Bedeutung die verbesserte Funktion für die Prognose in den ersten 6 Monaten bei LE-Patienten mit intermediärem Risiko hat.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    1) Alter ≥18 Jahre;
    2) Diagnose einer akuten LE, objektiv bestätigt durch eine Multidetektor-CT-Angiographie, Ventilations-/Perfusionsszintigraphie oder selektive invasive Pulmonalisangiographie entsprechend der etablierten diagnostischen Kriterien;
    3) Fehlen eines hämodynamischen Kollaps/einer Dekompensation bei Vorstellung;
    4) Kategorie des LE-Schweregrades mit intermediärem Risiko nach Diagnose einer akuten PE und mindestens einem der folgenden a-, b-, oder c-Kriterien bei Vorstellung:
    a) Mindestens ein Zeichen der RV-Drucküberlastung/Dysfunktion in der CT-Angiographie oder Echokardiographie:
    a1) in der CT-Angiographie ist die RV-Drucküberlastung/Dysfunktion definiert als Quotient der enddiastolischen Durchmesser von RV/LV >1,0; oder
    a2) in der Echokardiographie ist die RV-Drucküberlastung/ Dysfunktion definiert als das Vorhandensein von mindestens einem der folgenden Befunde:
    • Quotient der enddiastolischen Durchmesser von RV/LV >1,0 (apikaler oder subkostaler 4-Kammer-Blick);
    • Enddiastolischer Durchmesser von RV >30 mm (parasternale lange oder kurze Achse);
    • Hypokinesie der freien RV-Wand (jede Blickrichtung);
    • Trikuspidaler Regurgitationsjet >2.6 m/s im apikalen oder subkostalen 4-Kammerblick, oder in der kurzen Achse;
    • Fehlen eines inspiratorischen Kollapses der Vena cava inferior.
    b) Zeichen eines Myokardschadens, gekennzeichnet durch erhöhte Troponin-Spiegel:
    • Die Troponinerhöhung ist definiert als anormales Ergebnis jeden validierten Troponin-Tests, basierend auf den Referenzwerten, die durch die örtlichen Institute für Klinische Chemie an jedem teilnehmenden Studienort bestimmt werden;
    c) Zeichen des (RV)-Versagens, gekennzeichnet durch NT-proBNP-Spiegel >600 pg/ml
    5) Unterzeichnete und datierte Einverständniserklärung vorhanden.
    E.4Principal 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.
    1) Schwangerschaft oder Frauen im gebärfähigen Alter, die keine medizinisch akzeptierte hocheffektive Kontrazeption (während der Studie und bis zu 1 Monat nach Studienende) durchführen;
    2) Anwendung eines Fibrinolytikums, chirurgische Thrombektomie, interventionelle (Katheter-geführte) Thrombusaspiration oder -lyse, oder Anwendung eines Cava-Filters um die Indexepisode der LE zu behandeln;
    3) Notwendigkeit zur langfristigen Behandlung mit niedermolekularem Heparin, einem Vitamin K-Antagonisten oder einem neuen oralen Anti-koagulans (Rivaroxaban, Dabigatran, Apixaban oder Edoxaban) für eine andere Indikation als die Index LE-Episode; oder zur Therapie mit Thrombozytenaggregationshemmern außer Acetylsalicylsäure in einer Dosis ≤100 mg/Tag;
    4) Aktive Blutung oder bekanntes signifikantes Blutungsrisiko;
    5) Niereninsuffizienz mit einer geschätzten Kreatinin-Clearance < 30 ml/min/1,73m2;
    6) Fehlende Compliance oder Unfähigkeit, die Behandlung und die Kontrolltermine einzuhalten;
    7) Lebenserwartung weniger als 6 Monate.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is whether symptomatic VTE or PE-related death occurs within the first 6 months of anticoagulation therapy (yes/no). Symptomatic VTE and PE-related death are defined in chapter 2.2 of the Trial protocol.
    Primärer Endpunkt ist das Auftreten eines symptomatischen VTE-Rezidivs oder des Todes infolge einer LE innerhalb der ersten 6 Monate der Antikoagulation (ja/nein). Symptomatisches VTE-Rezidiv und LE-bedingter Tod sind im Abschnitt 2.2 des Prüfplans definiert.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after anticoagulation therapy
    6 Monate nach Antikoagulation
    E.5.2Secondary end point(s)
    1) Recovery of RV function at 6±1 days after PE diagnosis, or upon discharge (whichever comes first), and at 6-month follow-up, as assessed by echocardiography;
    2) Course of NT-proBNP levels during follow-up (measurement at baseline, 6±1 days or at discharge, and 6-month follow-up);
    3) Death from any cause, or hemodynamic collapse or decompensation, within the first 30 days;
    4) PE-related death, or PE-related hemodynamic collapse or decompensation, within the first 30 days;
    5) Overall duration of hospital stay (index event and repeated hospitalizations due to PE [index or recurrent event] or to a bleeding event) within 6 months;
    6) Death from any cause within 6 months.
    1) Erholung der RV-Funktion 6±1 Tage nach der Diagnose einer LE, oder bei Entlassung (je nachdem, was zuerst eintritt), und bei der Kontrolluntersuchung nach 6 Monaten, beurteilt durch eine Echokardiographie;
    2) Verlauf der NT-proBNP-Spiegel während der Nachbeobachtung (Messung zu Beginn, nach 6±1 Tagen oder bei Entlassung sowie bei der Kontrolluntersuchung nach 6 Monaten);
    3) Tod jeglicher Ursache oder hämodynamischer Kollaps oder Dekompensation innerhalb der ersten 30 Tage;
    4) Durch LE verursachter Tod oder durch LE verursachter hämodynamischer Kollaps oder Dekompensation innerhalb der ersten 30 Tage;
    5) Gesamter Krankenhausaufenthalt (Index-LE und wiederholte Krankenhausaufenthalte wegen LE [Indexepisode oder Rezidiv] oder wegen einer Blutung) innerhalb von 6 Monaten;
    6) Tod jeglicher Ursache innerhalb von 6 Monaten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days, 6 months after PE diagnosis
    30 Tage, 6 Monaten nach Diagnose LE
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    einarmig, prospektiv, interventionell
    single-arm, prospective, interventional
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last patient last visit (LPLV)
    Letzte Visite des letzten Studienteilnehmers
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 700
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Dabigatran as study medication will be taken for a period of 6 months. After that period continuation of anticoagulation and the anticoagulant drug to be used will be at the discretion of the patient’s physician.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-16
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