Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-13 @ 7:46 AM
Study NCT ID:
NCT04298567
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2020-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Learn More About the Safety and Effectiveness of Rivaroxaban (Xarelto) When Given Together With Acetylsalicylic Acid to Indian People With Narrowing of the Arteries of the Heart (CAD) and/or With Reduced Blood Flow in the Arteries of the Legs and Arms With Symptoms (Symptomatic PAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}, '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': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2020-02-19', 'studyFirstSubmitQcDate': '2020-03-05', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with haemorrhagic events and complications', 'timeFrame': 'Up to 13 months', 'description': 'Consisting of minor and major bleeding events. The major bleeding complications are collected according to the International Society on Thrombosis and Haemostasis (ISTH) criteria as a composite of fatal bleeding, symptomatic bleeding into a critical organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome), bleeding into surgical site requiring reoperation, bleeding leading to hospitalization.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with major adverse cardiovascular events (MACE)', 'timeFrame': 'Up to 13 months', 'description': 'MACE: composite of MI, stroke, and cardiovascular death (and single components)'}, {'measure': 'Number of participants with major adverse limb events (MALE)', 'timeFrame': 'Up to 13 months', 'description': 'MALE: Major adverse limb events, incl. major amputation (and single components), and antithrombotic treatment patterns after MALE'}, {'measure': 'Number of participants with thromboembolic events', 'timeFrame': 'Up to 13 months', 'description': 'Thromboembolic events includes systemic embolism, venous thromboembolism'}, {'measure': 'Number of participants with cardiovascular mortality', 'timeFrame': 'Up to 13 months'}, {'measure': 'Number of participants with all-cause mortality', 'timeFrame': 'Up to 13 months'}, {'measure': 'Number of participants with cardiac revascularization procedures', 'timeFrame': 'Up to 13 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 13 months'}, {'measure': 'Number of participants with carotid revascularization procedures', 'timeFrame': 'Up to 13 months'}, {'measure': 'Duration of hospitalizations', 'timeFrame': 'Up to 13 months', 'description': 'Hospitalizations includes stroke, cardiovascular reasons, MALE, or bleeding complications.'}, {'measure': 'Total and pain free walking distance per individual for PAD patients', 'timeFrame': 'Change from baseline up to 13 months'}, {'measure': 'Number of participants with history and diagnosis of CAD or PAD', 'timeFrame': 'Up to 13 months', 'description': 'History and diagnosis of CAD, incl. history of myocardial infarction and vessel status.\n\nHistory and diagnosis of PAD, incl. ankle-brachial index (ABI).'}, {'measure': 'Number of participants with individual risk', 'timeFrame': 'Up to 13 months', 'description': 'Individual Risk classification: Co-morbidities (e.g. worsening symptoms, diabetes mellitus, chronic heart failure (CHF) renal impairment (eGFR \\<60 ml/min), Cerebrovascular disease(, ≥ 2 peripheral vascular beds affected, intermittent claudication, ABI \\<0.9, smoking, hypertension, hyperlipidaemia, carotid stenosis), and routinely collected key laboratory data.'}, {'measure': 'Number of participants with revascularization procedures and prior interventions (PCI, CABG), peripheral revascularization procedures', 'timeFrame': 'Up to 13 months'}, {'measure': 'Type of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD', 'timeFrame': 'Up to 13 months'}, {'measure': 'Dose of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD', 'timeFrame': 'Up to 13 months'}, {'measure': 'Duration of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD', 'timeFrame': 'Up to 13 months'}, {'measure': 'Reasons and decision points for introducing rivaroxaban 2.5 mg [BID]', 'timeFrame': 'Up to 13 months', 'description': 'BID: twice per day dosing'}, {'measure': 'Reasons for discontinuation of rivaroxaban 2.5 mg [BID].', 'timeFrame': 'Up to 13 months'}, {'measure': 'Planned and actual duration of treatment with rivaroxaban 2.5 mg [BID].', 'timeFrame': 'Up to 13 months'}, {'measure': 'Planned and actual duration of treatment with ASA 75 mg [OD]', 'timeFrame': 'Up to 13 months', 'description': 'QD:once per day dosing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prevention of Atherothrombotic Events', 'Coronary Artery Disease (CAD)', 'Symptomatic Peripheral Artery Disease (Symptomatic PAD)']}, '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': 'This is an observational study in which data from Indian people with coronary artery disease and / or symptomatic peripheral artery disease who will be receiving the drug rivaroxaban (Xarelto) are studied.\n\nCoronary artery disease (CAD) is a condition where the arteries that bring blood and oxygen to the heart become hardened and narrow. Peripheral artery disease (PAD) is a condition with reduced blood flow in the arteries of the legs and arms. People with CAD and / or PAD with symptoms may receive rivaroxaban from their doctors to prevent problems (for example, stoke) caused by blood clots and hardening of the arteries.\n\nIn this study researcher want to gather more information on the safety and the effectiveness of rivaroxaban when given together with the drug acetylsalicylic acid (also known as "aspirin") to people with CAD and / or PAD with symptoms in the routine practice in India. Researchers are especially interested whether patients under treatment experience any events such as minor or major bleedings, stroke, sickness of the heart or blood vessels. In addition, information on why and when treating doctors decide to start or stop the treatment with rivaroxaban and acetylsalicylic acid is of interest to the researchers.\n\nThe study plans to enroll about 300 male or female patients who are at least 18 years old and are already treated with the two drugs or at least with rivaroxaban.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female and male patients with a diagnosis of CAD or symptomatic PAD will be enrolled within 4 weeks after the decision for treatment with rivaroxaban plus ASA has been made by the investigator.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥18 years) patient.\n* Diagnosis of CAD or PAD.\n* Treatment with Rivaroxaban 2.5mg tablet, co administered with acetylsalicylic acid (ASA), for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events within 4 weeks prior to enrolment. also patients already on rivaroxaban treatment for ACS, who are subsequently fulfilling criteria for CAD, are allowed to be enrolled within 4 weeks of this decision being made.\n* Patients who are willing to participate in this study (signed informed consent).\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 2.5mg given for CAD/PAD.\n* Participation in an interventional trial.'}, 'identificationModule': {'nctId': 'NCT04298567', 'briefTitle': 'Study to Learn More About the Safety and Effectiveness of Rivaroxaban (Xarelto) When Given Together With Acetylsalicylic Acid to Indian People With Narrowing of the Arteries of the Heart (CAD) and/or With Reduced Blood Flow in the Arteries of the Legs and Arms With Symptoms (Symptomatic PAD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Phase IV Study to Investigate the Safety and Effectiveness of Rivaroxaban(Xarelto) 2.5mg [BID]+Acetylsalicylic Acid(ASA) 75mg [OD] in Indian Patients With Coronary and/or Symptomatic Peripheral Artery Disease', 'orgStudyIdInfo': {'id': '21269'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment', 'description': 'Female and male patients with a diagnosis of CAD or symptomatic PAD will be enrolled within 4 weeks after the decision for treatment with rivaroxaban 2.5mg \\[BID\\] plus ASA 75mg \\[OD\\] has been made by the investigator.', 'interventionNames': ['Drug: Rivaroxaban (Xarelto,Bay 59-7939)', 'Drug: Acetylsalicylic acid(ASA)']}], 'interventions': [{'name': 'Rivaroxaban (Xarelto,Bay 59-7939)', 'type': 'DRUG', 'description': 'Rivaroxaban (2.5 mg \\[BID\\])', 'armGroupLabels': ['Treatment']}, {'name': 'Acetylsalicylic acid(ASA)', 'type': 'DRUG', 'description': 'ASA (75mg \\[QD\\]; dose according to local label.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'India', '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'}}}}