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    Summary
    EudraCT Number:2007-001685-33
    Sponsor's Protocol Code Number:07-002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-11-13
    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 number2007-001685-33
    A.3Full title of the trial
    Prospective Comparison of Phenpocoumon (Marcumar) and Acetylsalicylic Acid (ASS) as to Progression of the Valvular and Coronary Calcification.
    Prospektiver Vergleich von Phenprocoumon (Marcumar) und Acetylsalicylsäure (ASS) hinsichtlich der Progression der valvulären und koronaren Kalzifikation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of Marcumar and ASS as to Progression of Heart Valve Calcification
    Vergleich von Marcumar und ASS hinsichtlich des Fortschreiten der Herzklappen-Verkalkung
    A.3.2Name or abbreviated title of the trial where available
    ASS-Marcumar
    ASS-Marcumar
    A.4.1Sponsor's protocol code number07-002
    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 SponsorRWTH Aachen University
    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 supportKlinik für Kardiologie, Pneumologie, Angiologie und Internistische Intensivmedizin (Medizinische Klinik I)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTC-A
    B.5.2Functional name of contact pointStudienzentrum
    B.5.3 Address:
    B.5.3.1Street AddressPauwelsstraße 30
    B.5.3.2Town/ cityAachen
    B.5.3.3Post code52074
    B.5.3.4CountryGermany
    B.5.4Telephone number004924180092
    B.5.6E-mailvdeserno@ukaachen.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 Marcumar®
    D.2.1.1.2Name of the Marketing Authorisation holderMEDA Pharma GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 RoleComparator
    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 Aspirin® protect 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Treatment with oral anti-coagulants prevents thromboembolic complications e.g at atrial fibrillation or artificial heart valves. Primary objective of the study is the prospective comparison of the coronary and valvular Calcification on patients with newly induced long-term tehrapy with Phenprocoumon versus a patient colletive with ASS-therapy of the same age.
    Eine Behandlung mit oralen Antikoagulantien verhindert effektiv thrombembolische Komplikationen z.B. bei Vorhofflimmern
    oder künstlichem Herzklappenersatz. Primäres Ziel der Studie ist daher eine prospektiver Vergleich der Progression der
    koronaren und valvulären Kalzifikation bei Patienten mit neu eingeleiteter längerfristig geplanter Therapie mit
    Phenprocoumon versus einem altersgleichen Patientenkollektiv mit ASS-Therapie.
    E.1.1.1Medical condition in easily understood language
    In heart diseases anticoagulants prevent blood clots. In this study the effect of the anticoagulants Marcumar and ASS on the progression of heart valve calcification is studied.
    Bei Herzproblemen beugen Gerinnungshemmer der Bildung von Blutgerinnseln vor. Hier wird die Auswirkung der Gerinnungshemmer Marcumar und ASS auf das Forschreiten der Herzklappen-Verkalkung untersucht
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is the comparison of coronary and valvular progression of calcification in the multi-slice CT at patients with Phenprocoumon therapy versus patients with ASS therapy. Therefore the main objective is the change of the coronary and valvular calcification score determined in CT in both groups after 18 months in comparison to the initial value.
    Das Ziel dieser Studie ist der Vergleich der koronaren und valvulären Kalkprogression in der Mehrschicht-CT bei Patienten mit Phenprocoumontherapie versus Patienten mit ASS-Therapie. Daher wird als Hauptzielkriterium die Veränderung des im CT ermittelten koronaren und valvulären Kalzifikationsscores in beiden Gruppen nach 18 Monaten gegenüber dem Ausgangswert betrachtet.
    E.2.2Secondary objectives of the trial
    Important secondary objectives are the serum levels of calcification inhibitors (MGP, Fetuin, and OPG) and other markers of inflammation (hsCRP). These are correlated with the hemodynamic progression of a heart valve vitium and the progression of calcification. Furthermore, the valvular hemodynamic progression in echocardiography is compared in patients with Phenprocoumon therapy and patients with ASS therapy. Also, a comparison of the diastolic dysfunction in echocardiography in patients with Phenprocoumon and ASS therapy is done.
    In addition, the initial valvular and coronary calcification score schould be evaluated as predictor for subsequent cardial events as death, myocardial infarct or heart valve replacement. Morover a correlation of the progression of the calcification with the echocardiographic determined increase of a heart valve vitium is planned.
    Als wichtige Nebenzielkriterien der Studie werden die Serumspiegel von Kalzifikationsinhibitoren (MGP, Fetuin und OPG) sowie anderen Markern der Inflammation (hsCRP) untersucht und diese mit der hämodynamischen Progression eines Herzklappenvitiums sowie mit der Kalkprogression korreliert. Darüber hinaus ist der Vergleich der valvulären hämodynamischen Progression in der Echokardiographie bei Patienten mit Phenprocoumontherapie versus Patienten mit ASS-Therapie vorgesehen. Ferner soll ein Vergleich der diastolischen Dysfunktion in der Echokardiographie bei Patienten mit Phenprocoumontherapie versus Patienten mit ASS-Therapie erfolgen.
    Als weitere Nebenzielkriterien dieser Studie sollen der initialer valvulärer bzw. koronarer Kalkscore als Prädiktor für spätere kardiale Ereignisse wie Tod, Myokardinfarkt oder Klappenersatz evaluiert werden. Zudem erfolgt eine Korrelation der Kalkprogression mit der echokardiographisch bestimmten Zunahme eines Herzklappenvitiums.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Caucasian from 50 to 90 years
    - BMI from 19 to 27 kg/m²
    - (1) Patients with newly induced antcoagulation with Phenprocoumon, planned for at least 1 year. The most frequent indication for a Phenprocoumon thearpy are atrial fibrillation, heart valve replacement, and a strongly restricted LV function
    - or (2) control collective with the standard ASS therapy (100mg/d). The most frequent indication for this therapy is the coronary artery disease
    - persons, who are sui juris and mentally able to understand and follow the instructions of the study staff
    - signed informed consent
    - Kaukasier zwischen 50 und 90 Jahren
    - BMI zwischen 19 und 27 kg/m2
    - (1) Patienten mit neu einzuleitender Antikoagulation mit Phenprocoumon, über eine voraussichtliche Dauer von mindestens 1 Jahr. Die häufigsten Indikationen für eine solche Antikoagulation sind Vorhofflimmern, Klappenersatz und eine schwerst eingeschränkte LV-Funktion.
    - Oder (2) Kontrollkollektiv mit ASS-Standardtherapie von 100mg/d. Die häufigste Indikation für eine solche Therapie ist die koronare Herzkrankheit.
    - Personen, die geschäftsfähig sind und mental in der Lage die Anweisungen des Studienpersonals zu verstehen und ihnen Folge zu leisten
    - Unterschriebene Einwilligungserklärung
    E.4Principal exclusion criteria
    - renal insuffiency stage IV or V
    - acute cardiac or pulmonary decompensation
    - increased serum level of calcium
    - women of childbearing age or present pregenancy or lactation
    - psychiatric disease
    - individuals, who are accomodated in an instution on juridicial or official order
    - life expectancy <1 year
    - acute life-threatening condition of the patient
    - Individuals, who have a relationship of dependency to or work for the sponsor or the investigator
    - simultaneous participation in another clinical trial
    - Niereninsuffizienz Stadium IV oder V
    - Akute kardiale oder pulmonale Dekompensation
    - Erhöhte Serum-Calciumspiegel
    - Frauen im gebärfähigen Alter oder bestehende Schwangerschaft bzw. Stillzeit
    - Psychiatrische Erkrankung
    - Personen die auf gerichtliche oder behördliche Anordnung in einer Anstalt untergebracht sind
    - Erwartete Lebenserwartung < 1 Jahr
    - Akut lebensbedrohlicher Zustand des Patienten
    - Personen die in einem Abhängigkeitsverhältnis oder Arbeitsverhältnis zum Sponsor oder Prüfer stehen
    - Gleichzeitige Teilnahme an einer anderen klinischen Prüfung
    E.5 End points
    E.5.1Primary end point(s)
    Comparison
    Vergleich der mittel Mehrschicht-CT ermittelten koronaren und valvulären Kalzifikationsscores bei Patienten mit Phenprocoumontherapie versus Patienten mit ASS-Therapie nach 18 Monaten gegenüber dem Ausgangswert.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After last visit of last patient
    Nach der letzten Visite des letzten Patienten
    E.5.2Secondary end point(s)
    - comparison of serum levels of calcification inhibitors (MGP; Fetuin, OPG) and other markers of inflammation of both arms
    - correlation of these with the hemodynamc progression of heart valve vitium and the progression of calcification
    - comparison of the valvular hemodynamic progression in echocardigraphy in patients with phenprocoumon therapy versus patients with ASS therapy.
    - comparison of diastolic dysfunction in echocardiography in patients with phenprocoumon therapy versusu patients with ASS therapy
    - evaluation of the initial valvular and coronary calcification score as a predictor for subsequent cardiac events as death, myocardial infarct or artificial heart valves
    - correlation of the progression of the calcification with the increase of a heart valve vitium assigned with echocardiography
    E.5.2.1Timepoint(s) of evaluation of this end point
    After last visit of last patient
    Nach der letzten Visite des letzten Patienten
    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 No
    E.6.5Efficacy No
    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 Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state120
    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)
    normal treatment of that condition
    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 Decision2007-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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