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    Summary
    EudraCT Number:2019-001723-12
    Sponsor's Protocol Code Number:ARIVA_venous
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-28
    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 ConcernedAustria - BASG
    A.2EudraCT number2019-001723-12
    A.3Full title of the trial
    Aspirin® plus rivaroxaban versus rivaroxaban alone for the prevention of venous stent thrombosis in patients with post-thrombotic syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Aspirin® plus rivaroxaban versus rivaroxaban alone for the prevention of venous stent thrombosis in patients with post-thrombotic syndrome (long-term condition associated with redness, swelling, leg pain, and ulcers as a results of deep vein thrombosis)
    A.3.2Name or abbreviated title of the trial where available
    ARIVA venous
    A.4.1Sponsor's protocol code numberARIVA_venous
    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 SponsorUniversitätsspital Zürich, Klinik für Angiologie
    B.1.3.4CountrySwitzerland
    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 supportUniversitätsspital Zürich, Klinik für Angiologie
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportBayer (Schweiz) AG
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportBARD Medica S.A.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsspital Zürich
    B.5.2Functional name of contact pointKlinik für Angiologie
    B.5.3 Address:
    B.5.3.1Street AddressRämistr. 100
    B.5.3.2Town/ cityZürich
    B.5.3.3Post code8091
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number00410432530371
    B.5.5Fax number00410432544202
    B.5.6E-mailelaine.probst@usz.ch
    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 Aspirin protect 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Austria Ges.m.b.H.
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameAspirin protect 100 mg
    D.3.4Pharmaceutical form Film-coated 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 INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Post-thrombotic syndrome
    E.1.1.1Medical condition in easily understood language
    Post-thrombotic syndrome is a long-term complication of a deep vein thrombosis. It may include following symptoms: pain, swelling, itching , red/brown skin discoloration and ulcer at the affected leg.
    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
    To show if additional therapy with Aspirin® is more efficient than basic medication alone in the prevention of early venous stent thrombosis in patients suffering from post-thrombotic syndrome in the first 6 months following endovascular therapy.
    E.2.2Secondary objectives of the trial
    To demonstrate tolerability of additional therapy with Aspirin® to basic medication in long-term treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent form and - in EU countries only - data protection declaration obtained prior to any trial-specific procedures
    2. Patient aged ≥18 and <75 years
    3. Confirmed diagnosis of post-thrombotic syndrome defined as Villalta score > 4 points prior to enrolment and venous stent intervention
    4. Confirmed stenosis of inferior vena cava, iliac vein, or common femoral vein by duplex ultrasound or cross-sectional imaging (CT venography or MR venography) prior to enrolment and venous stent intervention
    5. Successfully conducted venous stent intervention involving either:
    o inferior vena cava
    o iliac vein or
    o common femoral vein
    6. Patients on active treatment with rivaroxaban
    E.4Principal exclusion criteria
    1. Previous venous intervention in target vessels
    2. Any contraindication for antithrombotic therapy (e.g. active gastric ulcer, duodenal ulcer, bleeding disorder with increased tendency of bleedings)
    3. Patients with any history of gastrointestinal or urogenital bleeding except menstrual bleeding
    4. Patients with a recent (3 months) clinically significant bleeding and / or active or recent (3 months) ulcerative or inflammatory gastrointestinal disease (including esophagitis and gastro-esophageal reflux disease)
    5. Patients with a significant risk for severe bleeding, e.g. recent (3 months) brain or spinal cord injuries, recent (3 months) brain, spinal cord or eye surgery, recent (3 months) intracranial bleeding, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysm, larger intraspinal or intracerebral vascular anomalies
    6. Intake (concomitantly and / or within 7 days prior to Visit 1) of anticoagulants (heparins including derivatives [except of use of unfractionated heparin on the day intervention and the use of enoxaparin instead of rivaroxaban within 2 weeks after Visit 1], oral anticoagulants [except of use of rivaroxaban], thrombolytics, antiplatelet treatment and acetylsalicylic acid [except of use of IMP])
    7. Acute thrombosis (venous thromboembolism events < 3 months prior to Visit 1) or previous thrombosis with diagnosed antiphospholipid syndrome
    8. Pre-existing coagulopathy and / or hemorrhagic diathesis
    9. Uncontrolled severe arterial hypertension
    10. Vascular retinopathy
    11. Bronchiectasia, history of pulmonic bleedings and / or asthma attack caused by use of salicylates or drugs with similar effects, especially NSAIDs
    12. Acute bacterial endocarditis
    13. Prior stroke or transient ischemic attack (< 12 months prior to Visit 1)
    14. Hereditary galactose intolerance, total lactase deficiency, glucose-galactose malabsorption and / or severe glucose-6-phosphate-dehydrogenase deficiency
    15. Pregnancy, breast feeding, or planned pregnancy within the trial period or women of childbearing potential not using an adequate method of contraception
    16. Severe heart, liver (including those associated with a coagulopathy) or kidney (e.g. eGFR < 50 mL/min)or kidney (e.g. eGFR < 50 mL/min) disease
    17. Severe somatopathic, neurological and / or psychiatric disease(s)
    18. Malignant growth (concurrent or previous cancer with a relapse-free and treatment-free interval of less than 5 years before Visit 1)
    19. Known hypersensitivity to acetylsalicylic acid (Aspirin® cardio or Aspirin® protect and / or its excipients), to other antiphlogistic drugs, to analgesics, to anti-fever drugs or to rivaroxaban (Xarelto® and / or its excipients)
    20. Concomitant intake of methotrexate > 15 mg per week, strong inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (azole antimycotics, e.g. ketoconazole; HIV protease inhibitors), strong inductors of CYP3A4 (rifampicin, phenytoin, carbamazepine, phenobarbital or St. John’s wort), dronedarone, digoxin, valproic acid, selective serotonin reuptake inhibitors (SSRI), serotonin noradrenalin reuptake inhibitors (SNRI), systemic glucocorticoids and / or non-steroidal anti-inflammatory drugs (NSAIDs; long-term use)
    21. Parallel participation in another clinical trial, participation in a clinical trial within less than 6 weeks prior to the Screening visit or previous participation in this clinical trial
    22. Known to be, or suspected of being unable to comply with the trial protocol (e.g. no permanent address, history of drug or alcohol abuse, known to be non-compliant or presenting an unstable psychiatric history)
    23. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
    24. Custody by juridical or official order
    25. Evidence of an uncooperative attitude
    26. Difficulties in understanding the language in which the patient information is given
    27. Patients dependent from the investigator or sponsor (e.g. close relatives of the investigator, employees of the clinic, the sponsor or involved CRO(s))
    E.5 End points
    E.5.1Primary end point(s)
    The primary patency rate after 6 months (=Visit 3) is considered to be the primary endpoint.
    The primary patency rate is defined as the percentage of patients with primary treatment success, i.e. without the occurrence of either i) occlusion of at least a part of the stent segment or ii.) a re-intervention to maintain patency of the treated segment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 months (Visit 3)
    E.5.2Secondary end point(s)
    1. Primary patency rate after 3 months (= Visit 2).
    2. Secondary patency rate after 3 and 6 months (= Visit 2 & 3): Secondary patency rate is defined as the percentage of patients with primary treatment success and without the occurrence of occlusion of at least a part of the stent , irrespective of any re-intervention.
    3. Primary sustained clinical success after 3 and 6 months (=Visit 2 & 3): Primary sustained clinical success, defined as the absence of post-thrombotic syndrome (Villalta score 0-4 points) without the need for re-intervention assessed at the latest routine follow-up visit (at the latest available follow-up).
    4. Incidence of patients with open stents but >50% residual stenosis according Duplex criteria.
    5. Difference of limb circumference of the affected leg in comparison to the contralateral leg at 3 and 6 months (=Visit 2 & 3), respectively, compared to baseline (for patients with only one affected leg)
    6. Quality of life using the CIVIQ-20 (chronic venous insufficiency quality of life questionnaire) at 3 and 6 months (=Visit 2 & 3) compared to baseline.
    7. Villalta score with and without “ulcus cruris assessment” at 3 and 6 months (= Visit 2 & 3), respectively, compared to baseline
    8. Revised venous clinical severity score (rVCSS), at 3 and 6 months (= Visit 2 & 3), respectively, compared to baseline
    9. Investigator's and patient's global judgement on efficacy after 6 months of treatment
    10. Incidences of adverse events / adverse reactions with a special focus on bleedings (major, clinical relevant non‐major bleeding and minor according to ISTH classification) and death (VTE-related, bleeding-related, other).
    11. Investigator's and patient's global judgement on tolerability after 6 months of treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    Ad 1: After 3 months (Visit 2)
    Ad 2: After 3 and 6 months (Visit 2 and 3)
    Ad 3: After 3 and 6 months (Visit 2 and 3)
    Ad 4: After 6 months (Visit 3)
    Ad 5: After 3 and 6 months (Visit 2 and 3)
    Ad 6: After 3 and 6 months (Visit 2 and 3)
    Ad 7: After 3 and 6 months (Visit 2 and 3)
    Ad 8: After 3 and 6 months (Visit 2 and 3)
    Ad 9: After 6 months (Visit 3)
    Ad 10: After 6 months (Visit 3)
    Ad 11: After 6 months (Visit 3)
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Rivaroxaban 20 mg per day (basic therapy)
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    Germany
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months30
    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: 266
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 316
    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)
    Treatment after the subject has ended the participation in the trial: expected 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 Decision2020-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-28
    P. End of Trial
    P.End of Trial StatusOngoing
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