Ignite Creation Date:
2025-12-24 @ 1:01 PM
Ignite Modification Date:
2026-01-01 @ 5:24 AM
Study NCT ID:
NCT04401761
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2020-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Collect Data on the Treatment Pattern of Xarelto + Acetylsalicylic Acid in the Routine Clinical Practice in Patients Who Are Suffering From a Condition That Narrows the Blood Vessels Supplying the Heart and / or a Condition That Most Commonly Narrows the Blood Vessel in the Legs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Canada', 'Saudi Arabia', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3189}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2020-05-22', 'studyFirstSubmitQcDate': '2020-05-22', 'lastUpdatePostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health status by questionnaire EQ-5D-5L', 'timeFrame': 'Up to 34 months', 'description': 'Self-reported health-related quality of life is measured with EQ-5D at the initial visit and at each follow-up visit. Items are scored from 1 (no problems) to 5 (extreme problems) leading to a total score from 0 (worst imaginable health) to 100 (best imaginable health).'}, {'measure': 'Descriptive analysis of clinical characteristics of CAD participants', 'timeFrame': 'At baseline'}, {'measure': 'Descriptive analysis of clinical characteristics of PAD participants', 'timeFrame': 'At baseline'}, {'measure': 'Descriptive analysis of prior antithrombotic treatment', 'timeFrame': 'At baseline'}, {'measure': 'Descriptive analysis of concomitant antithrombotic treatment', 'timeFrame': 'Upto 34 months'}, {'measure': 'Descriptive analysis of prior secondary prevention therapies', 'timeFrame': 'At baseline'}, {'measure': 'Descriptive analysis of concomitant secondary prevention therapies', 'timeFrame': 'Up to 34 months'}, {'measure': 'Reason to start rivaroxaban', 'timeFrame': 'At baseline', 'description': 'Reasons include past ischemic events, co-morbidities and medical history.'}, {'measure': 'Decision point to start rivaroxaban', 'timeFrame': 'At baseline', 'description': 'Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events'}, {'measure': 'Reasons for discontinuation of rivaroxaban', 'timeFrame': 'Up to 34 months'}, {'measure': 'Planned duration of treatment with rivaroxaban', 'timeFrame': 'At baseline'}, {'measure': 'Actual duration of treatment with rivaroxaban', 'timeFrame': 'Up to 34 months'}, {'measure': 'Planned duration of treatment with Acetylsalicylic acid (ASA)', 'timeFrame': 'At baseline'}, {'measure': 'Actual duration of treatment with ASA', 'timeFrame': 'Up to 34 months'}], 'secondaryOutcomes': [{'measure': 'Number of participants with major adverse cardiovascular events (MACE)', 'timeFrame': 'Up to 34 months', 'description': 'Composite endpoint comprising of myocardial infarction, stroke, and cardiovascular death (and single components).'}, {'measure': 'Number of participants with major adverse limb events (MALE)', 'timeFrame': 'Up to 34 months', 'description': 'Major adverse limb events comprise acute limb ischemia and vascular amputation, and antithrombotic treatment \\[pattern\\] after MALE.'}, {'measure': 'Number of participants with antithrombotic treatment after MALE', 'timeFrame': 'Up to 34 months'}, {'measure': 'Number of participants with MACE or MALE', 'timeFrame': 'Up to 34 months', 'description': 'Composite endpoint comprising myocardial infarction, ischemic stroke, cardiovascular death, acute limb ischemia, major amputation of vascular etiology.'}, {'measure': 'Number of participants with thromboembolic events', 'timeFrame': 'Up to 34 months', 'description': 'Thromboembolic events include e.g. systemic embolism and venous thromboembolism.'}, {'measure': 'Number of participants with haemorrhagic events and complications', 'timeFrame': 'Up to 34 months', 'description': 'The major bleeding complications will be collected according to the International Society on Thrombosis and Haemostasis (ISTH) criteria, modified ISTH criteria, and Thrombolysis in Myocardial Infarction (TIMI) criteria.'}, {'measure': 'Number of deaths due to cardiovascular events', 'timeFrame': 'Up to 34 months'}, {'measure': 'Number of deaths due to any cause', 'timeFrame': 'Up to 34 months'}, {'measure': 'Number of participants with cardiac revascularization procedures', 'timeFrame': 'Up to 34 months', 'description': 'Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)'}, {'measure': 'Number of participants with peripheral revascularization procedures', 'timeFrame': 'Up to 34 months'}, {'measure': 'Number of participants with lower limb revascularization procedures.', 'timeFrame': 'Up to 34 months'}, {'measure': 'Number of participants with carotid revascularization procedures', 'timeFrame': 'Up to 34 months'}, {'measure': 'Number of hospitalizations', 'timeFrame': 'Up to 34 months', 'description': 'Number of hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.'}, {'measure': 'Duration of hospitalizations', 'timeFrame': 'Up to 34 months', 'description': 'Hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.'}, {'measure': 'Total walking distance per individual for PAD participants', 'timeFrame': 'Up to 34 months'}, {'measure': 'Pain free walking distance per individual for PAD participants', 'timeFrame': 'Up to 34 months'}, {'measure': 'Patient-reported walking impairment by Walking Impairment Questionnaire (WIQ) for PAD participants', 'timeFrame': 'Up to 34 months', 'description': 'The WIQ is a validated questionnaire that measures patient-reported walking limitations in distance, stair climbing and speed. Final score ranges from 0 (unable to walk) to 4 (no difficulty to walk).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thrombosis'], 'conditions': ['Coronary Artery Disease', 'Peripheral Artery Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': 'Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.'}]}, 'descriptionModule': {'briefSummary': 'The study will focus on effectiveness and safety of rivaroxaban (Xarelto) when given together with acetylsalicylic acid (combination therapy) to patients suffering from coronary artery disease (a condition that affects the blood vessels supplying the heart) and / or peripheral artery disease (a condition that affects the blood vessels of the lower limbs) in the routine clinical practice. The study will help to collect data for prevention cardiovascular death, myocardial infarction (MI), stroke and major adverse limb events in adult patients. The study will focus on information on when and why physicians are starting to treat patients with combination therapy, treatment duration, reasons to discontinue treatment and previous therapies. The study will also investigate treatment outcomes for patients being treated with a combination therapy by their physicians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'International population of adult CAD/PAD patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥18 years) patient (except Taiwan ≥ 20 years old).\n* Diagnosis of CAD or symptomatic PAD.\n* Treatment according to local marketing authorization, rivaroxaban 2.5 mg \\[BID\\] plus Acetylsalicylic acid (ASA) 75-100 mg \\[OD\\] started up to 4 weeks before or after the ICF is signed.\n* Only in those countries with a marketing authorization of rivaroxaban in the Acute Coronary Syndrome (ACS) indication, patients already on rivaroxaban treatment for ACS for more than 4 weeks, who are subsequently fulfilling criteria for CAD, are also allowed to be enrolled.\n\nExclusion Criteria:\n\n* Contra-indications according to the local marketing authorization.\n* Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD.\n* Participation in an interventional trial.\n* Enrolment in the XATOA study.'}, 'identificationModule': {'nctId': 'NCT04401761', 'acronym': 'XATOC', 'briefTitle': 'A Study to Collect Data on the Treatment Pattern of Xarelto + Acetylsalicylic Acid in the Routine Clinical Practice in Patients Who Are Suffering From a Condition That Narrows the Blood Vessels Supplying the Heart and / or a Condition That Most Commonly Narrows the Blood Vessel in the Legs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes Across the Disease Continuum in Patients With CAD and/or PAD', 'orgStudyIdInfo': {'id': '21283'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CAD/PAD-patients', 'description': 'Adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) who are treated with a combination of rivaroxaban and acetylsalicylic acid.', 'interventionNames': ['Drug: Rivaroxaban (BAY59-7939, Xarelto)', 'Drug: Acetylsalicylic acid']}], 'interventions': [{'name': 'Rivaroxaban (BAY59-7939, Xarelto)', 'type': 'DRUG', 'otherNames': ['Xarelto'], 'description': '2.5 mg twice daily', 'armGroupLabels': ['CAD/PAD-patients']}, {'name': 'Acetylsalicylic acid', 'type': 'DRUG', 'otherNames': ['Aspirin'], 'description': '75 - 100 mg once daily at the discretion of the investigator', 'armGroupLabels': ['CAD/PAD-patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Belgium', 'facility': 'Many Locations'}, {'city': 'Multiple Locations', 'country': 'China', 'facility': 'Many Locations'}, {'city': 'Multiple Locations', 'country': 'Colombia', 'facility': 'Many Locations'}, {'city': 'Multiple Locations', 'country': 'Italy', 'facility': 'Many Locations'}, {'city': 'Multiple Locations', 'country': 'Russia', 'facility': 'Many Locations'}, {'city': 'Multiple Locations', 'country': 'Slovenia', 'facility': 'Many Locations'}, {'city': 'Multiple Locations', 'country': 'South Korea', 'facility': 'Many Locations'}, {'city': 'Multiple Locations', 'country': 'Spain', 'facility': 'Many Locations'}, {'city': 'Multiple Locations', 'country': 'Switzerland', 'facility': 'Many Locations'}, {'city': 'Multiple Locations', 'country': 'Taiwan', 'facility': 'Many Locations'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Availability of this study\'s data will later be determined according to Bayer\'s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.\n\nInterested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}