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    The EU Clinical Trials Register currently displays   44313   clinical trials with a EudraCT protocol, of which   7357   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-003573-32
    Sponsor's Protocol Code Number:2022/ABM/01/00027
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-12-20
    Trial 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2022-003573-32
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled study to evaluate the effect of allopurinol on the risk of cardiovascular events in patients at high and very high cardiovascular risk, including the presence of long-COVID syndrome.
    „Randomizowane, podwójnie zaślepione, kontrolowane placebo badanie oceniające wpływ allopurynolu na ryzyko zdarzeń sercowo-naczyniowych u pacjentów z wysokim i bardzo wysokim ryzykiem sercowo-naczyniowym, z uwzględnieniem obecności zespołu Long-COVID.”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Allopurinol as a preventive drug in patients with high and very high cardiovascular risk, taking into account the presence of the long-COVID syndrome.
    Allopurynol jako lek prewencyjny u pacjentów wysokiego i bardzo wysokiego ryzyka sercowo-naczyniowego z uwzględnieniem obecności zespołu long-COVID.
    A.3.2Name or abbreviated title of the trial where available
    ALL-VASCOR
    ALL-VASCOR
    A.4.1Sponsor's protocol code number2022/ABM/01/00027
    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 SponsorUniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
    B.1.3.4CountryPoland
    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 supportMedical Research Agency
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMD Paweł Uruski
    B.5.2Functional name of contact pointMD Paweł Uruski
    B.5.3 Address:
    B.5.3.1Street AddressDługa 1/2
    B.5.3.2Town/ cityPoznań
    B.5.3.3Post code61-848
    B.5.3.4CountryPoland
    B.5.4Telephone number+48618549090
    B.5.6E-mailpuruski@ump.edu.pl
    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 Milurit (Allopurinolum) 200mg
    D.2.1.1.2Name of the Marketing Authorisation holderPROTERAPIA sp. z o.o.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameMilurit (Allopurinolum)
    D.3.4Pharmaceutical form Tablet
    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 INNAllopurinol
    D.3.9.1CAS number 315-30-0
    D.3.9.4EV Substance CodeSUB05338MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    hyperuricemia, hypertension, ischemic stroke, intracerebral haemorrhage, TIA, heart failure, peripheral arterial disease, atrial fibrillation, diabetes mellitus
    hiperurykemia, nadciśnienie tętnicze, udar niedokrwienny, krwawienie domózgowe, TIA, niewydolność serca, choroba tętnic obwodowych, migotanie przedsionków, cukrzyca
    E.1.1.1Medical condition in easily understood language
    hyperuricemia, hypertension, ischemic stroke, intracerebral haemorrhage, TIA, heart failure, peripheral arterial disease, atrial fibrillation, diabetes mellitus
    hiperurykemia, nadciśnienie tętnicze, udar niedokrwienny, krwawienie domózgowe, TIA, niewydolność serca, choroba tętnic obwodowych, migotanie przedsionków, cukrzyca
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10020907
    E.1.2Term Hyperuricemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10020772
    E.1.2Term Hypertension
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10044390
    E.1.2Term Transient ischaemic attack
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019279
    E.1.2Term Heart failure
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012601
    E.1.2Term Diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.1
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In patients with very high and high cardiovascular risk, the use of allopurinol will reduce cardiovascular risk, in the entire study population and in the group over 60 years of age.
    U chorych z bardzo wysokiego i wysokiego ryzyka sercowo naczyniowego stosowanie allopurynolu obniży ryzyko sercowo-naczyniowe, w całej badanej populacji i w grupie powyżej 60 r.ż.
    E.2.2Secondary objectives of the trial
    Occurrence of a major cardiovascular event (MACE) such as all cause death, cardiac death, stroke/TIA, acute coronary syndrome, coronary artery angioplasty or revascularization, peripheral arterial angioplasty, hospitalization for unstable angina, or worsening heart failure (hospitalization and stay in the emergency room / Hospital Emergency Department due to heart failure, the need for intravenous loop diuretic and/or doubling the dose of oral loop diuretic).
    Wystąpienie poważnego zdarzenia sercowo-mózgowego (MACE), takiego jak zgon z wszystkich przyczyn, zgon sercowy, udar mózgu/TIA, ostry zespół wieńcowy, angioplastyka lub rewaskularyzacja chirurgiczna tętnic wieńcowych, angioplastyka tętnic obwodowych, hospitalizacja z powodu niestabilnej dławicy piersiowej lub zaostrzenia niewydolności serca (hospitalizacja i pobyt na izbie przyjęć/ Szpitalny Oddział Ratunkowy z powodu niewydolności serca, konieczność użycia dożylnego diuretyku pętlowego i/lub podwojenie dawki doustnego diuretyku pętlowego).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age: between 40 and 70 years old
    2. Giving informed consent to participate in the study
    3. Serum uric acid above 5mg/dl within the last 6 months for screening
    4. At least one of the criteria for very high or high cardiovascular risk:
    a. calculated 10-year risk of death from cardiovascular causes according to SCORE2 >2.5% for patients <50 years of age or ≥5% for patients ≥50 years of age
    b. documented occurrence of cardiovascular diseases (cerebrovascular disease: ischemic stroke, intracerebral bleeding, TIA; heart failure regardless of the etiology NYHA I - II, peripheral arterial disease PAD, atrial fibrillation (de novo or ever in history)
    c. diabetes or hypertension complicated by organ damage:
    i. increase in vascular stiffness: pulse pressure ≥ 60 mmHg, and/or cervicofemoral pulse wave velocity > 10 m/s
    ii. features of left ventricular hypertrophy on echocardiography or electrocardiography
    iii. elevated albumin-creatinine ratio in the urine sample (30-300 mg/g)
    iv. ankle-brachial index < 0.9.
    1.Wiek: w przedziale 40 –70 r.ż.
    2.Wyrażenie świadomej zgody na udział w badaniu
    3.Stężenie kwasu moczowego w surowicy powyżej 5 mg/dl w przeciągu ostatnich 6 miesięcy do screeningu
    4.Spełnienie przynajmniej jednego z kryteriów określających bardzo wysokie lub wysokie ryzyko sercowo-naczyniowe:
    a. wyliczone 10-letnie ryzyko zgonu z przyczyn sercowo-naczyniowych wg. SCORE2 >2,5% dla pacjentów <50 roku życia lub ≥ 5% dla pacjentów ≥ 50 roku życia
    b. udokumentowane występowanie chorób sercowo-naczyniowych (choroba naczyń mózgowych: udar niedokrwienny, krwawienie domózgowe, TIA; niewydolność serca bez względu na etiologię NYHA I -II, choroba tętnic obwodowych PAD, migotanie przedsionków (de novo lub kiedykolwiek w historii)
    c. cukrzyca lub nadciśnienie tętnicze powikłane uszkodzeniami narządowymi:
    i. wzrost sztywności naczyniowej: ciśnienie tętna ≥ 60 mmHg, i/lub szyjno-udowa prędkość fali tętna > 10 m/s
    ii. cechy przerostu lewej komory w badaniu echokardiograficznym lub elektrokardiograficznym
    iii. podwyższony wskaźnik albumina–kreatynina w próbce moczu (30–300 mg/g)
    iv. wskaźnik kostka–ramię < 0,9.
    E.4Principal exclusion criteria
    1. Taking allopurinol, febuxostat or other hypouricemic drugs within the last 6 months for screening.
    2. Contraindications to taking allopurinol preparation.
    3. Women who are pregnant, lactating or planning to become pregnant during the study.
    4. Hormone therapy containing estrogens.
    5. Active neoplastic process or neoplastic disease in the last 5 years, excluding locally malignant neoplasms.
    6. Uncontrolled hypertension (mean value ≥ 180/110 mmHg on the 7th day preceding the screening visit) in home measurements despite the use of antihypertensive drugs.
    7. Renal failure with renal filtration rate eGFR <45 ml/min/ 1.73 m2 (according to recommendations of 2009 CKD-EPI G3b, G4 and G5).
    8. Hypothyroidism or hyperthyroidism not in a euthyroid state.
    9. Confirmed ischemic heart disease (defined as: history of AMI, myocardial revascularization or or the occurrence of angina symptoms accompanied by atherosclerotic changes in coronary vessels > 50% detected in computed tomography or coronary angiography).
    10. Heart failure in class III and IV according to NYHA.
    11. Taking preparations: azathioprine, mercaptopurine, cyclosporine.
    12. Participation in another clinical trial on a medicinal product or medical device within the last 3 months or 5 half-lives, whichever is longer
    13.Diagnosed liver cirrhosis regardless of etiology.
    14.Aspartate and/or alanine transaminase activity exceeding 3 times the upper limit of normal during the screening period.
    1.Przyjmowanie preparatów allopurynolu, febuksostatu lub innego leku hipourykemicznego w przeciągu ostatnich 6 miesięcy do screeningu.
    2.Przeciwwskazania do przyjmowania preparatu allopurynolu.
    3.Kobiety ciężarne, w okresie laktacji lub planujące ciążę w trakcie trwania badania.
    4.Terapia hormonalna zawierająca estrogeny.
    5.Aktywny proces nowotworowy lub choroba nowotworowa w ostatnich 5 latach z wyłączeniem nowotworów miejscowo złośliwych.
    6.Niekontrolowane nadciśnienie tętnicze (średnia wartość ≥ 180/110 mmHg z 7 dnia poprzedzającego wizytę screeningową) w pomiarach domowych pomimo stosowania leków hipotensyjnych.
    7.Niewydolność nerek ze wskaźnikiem filtracji nerek eGFR <45 ml/min/ 1,73m2 (wg zaleceń 2009 CKD-EPI G3b, G4 oraz G5).
    8.Niedoczynność lub nadczynność tarczycy nie w stanie eutyreozy.
    9.Potwierdzona choroba niedokrwienna serca (definiowana jako: przebyty AMI, rewaskularyzacja mięśnia sercowego lub występowanie objawów dławicowych z towarzyszącymi zmianami miażdżycowymi w naczyniach wieńcowych > 50% stwierdzonymi w tomografii komputerowej lub w koronarografii ).
    10.Niewydolność serca w klasie III i IV wg NYHA.
    11.Przyjmowanie preparatów: azatiopryny, merkaptopuryny, cyklosporyny.
    12.Udział w innym badaniu klinicznym dotyczącym produktu leczniczego lub sprzętu medycznego w przeciągu ostatnich 3 miesięcy lub 5 okresów półtrwania w zależności, który okres jest dłuższy
    13.Rozpoznana marskość wątroby niezależnie od etiologii.
    14.Aktywność transaminazy asparaginianowej i/lub alaninowej przekraczająca 3- krotność górnej granicy normy w okresie screeningowym.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of a major cardiovascular event (MACE) such as all cause death, cardiac death, stroke/TIA, acute coronary syndrome, coronary artery angioplasty or revascularization, peripheral arterial angioplasty, hospitalization for unstable angina, or worsening heart failure (hospitalization and stay in the emergency room / Hospital Emergency Department due to heart failure, the need for intravenous loop diuretic and/or doubling the dose of oral loop diuretic).
    Wystąpienie poważnego zdarzenia sercowo-mózgowego (MACE), takiego jak zgon z wszystkich przyczyn, zgon sercowy, udar mózgu/TIA, ostry zespół wieńcowy, angioplastyka lub rewaskularyzacja chirurgiczna tętnic wieńcowych, angioplastyka tętnic obwodowych, hospitalizacja z powodu niestabilnej dławicy piersiowej lub zaostrzenia niewydolności serca (hospitalizacja i pobyt na izbie przyjęć/ Szpitalny Oddział Ratunkowy z powodu niewydolności serca, konieczność użycia dożylnego diuretyku pętlowego i/lub podwojenie dawki doustnego diuretyku pętlowego).
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of the trial
    zakończenie badania
    E.5.2Secondary end point(s)
    end of the trial
    zakończenie badania
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of the trial
    zakończenie badania
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 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 concerned12
    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 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
    LVLS
    Ostatnia wizyta ostatniego pacjenta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days26
    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: 771
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 345
    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 state1116
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1116
    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)
    None
    Nie dotyczy
    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 Decision2023-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-12
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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