[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657051":3},{"organization":4,"outcomesModule":7,"designInfo":15,"detailedDescription":11,"studyPopulation":11,"armGroups":21,"interventions":32,"overallOfficials":11,"centralContacts":41,"locations":47,"responsibleParty":64,"collaborators":11,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":11,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":50,"whyStopped":11,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"King Edward Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Major Adverse Limb Events (MALEs)",null,"6 months",{"measure":14,"description":11,"timeFrame":12},"Major Adverse Cardiovascular Events",{"allocation":16,"interventionModel":17,"interventionModelDescription":11,"primaryPurpose":18,"observationalModel":11,"timePerspective":11,"maskingInfo":19},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":20,"maskingDescription":11,"whoMasked":11},"NONE",[22,27],{"label":23,"type":24,"description":11,"interventionNames":25},"Aspirin","ACTIVE_COMPARATOR",[26],"Drug: Aspirin tablet",{"label":28,"type":24,"description":29,"interventionNames":30},"Low-Dose Rivaroxaban and Aspirin,","Low dose Rivaroxaban 2.5 mg used orally twice a day in combination with Aspirin is a vascular protective dose as described in COMPASS and VOYEGAR PAD trials. This low dose has antithrombotic effect without full anticoagulation ,thus less bleeding risk compared to standard anticoagulant dose.",[31],"Drug: Low-Dose Rivaroxaban Plus Aspirin,",[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":11},"DRUG","Aspirin tablet","75 mg once daily",[23],{"type":34,"name":39,"description":29,"armGroupLabels":40,"otherNames":11},"Low-Dose Rivaroxaban Plus Aspirin,",[28],[42],{"name":43,"role":44,"phone":45,"phoneExt":11,"email":46},"Hafsa Farooq, MBBS","CONTACT","+923335700188","hafsafarooqiqbal.99@gmail.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Mayo Hospital Lahore","RECRUITING","Lahore","Punjab Province","54000","Pakistan","PK",{"type":57,"coordinates":58},"Point",[59,60],74.35071,31.558,{"lat":60,"lon":59},[63],{"name":43,"role":44,"phone":45,"phoneExt":11,"email":46},{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","javeria khalid","principle investigator","100657051","early-phase-1-comparison-of-aspirin-alone-versus-low-dose-rivaroxaban-plus-aspirin-in-chronic-limb-threatening-ischemia-100657051",false,"NCT07832578","Comparison of Aspirin Alone Versus Low-Dose Rivaroxaban Plus Aspirin in Chronic Limb-Threatening Ischemia","Comparison of Outcomes of Chronic Limb Threatening Ischemia in Diabetic and Hypertensive Patients With Hypercholesterolemia: Aspirin Alone Versus Low-Dose Rivaroxaban Plus Aspirin, in Mayo Hospital, Lahore","Inclusion Criteria:\n\n* All patients of CLTI managed conservatively\n* ASA score of 3 or more\n* Age 40-70 yrs\n* Diagnosed case of Diabetes mellitus type 2 (HbA1c \\>8)\n* Blood Pressue ( \\>130\u002F90 , \\\u003C180\u002F100 )\n* Hypercholestrolemia (Total cholesterol ≥200 mg\u002FdL )\n* ABPI \\\u003C 0.6\n* Claudication distance \\\u003C 100 meters\n* Provided written informed consent (for prospective or interventional studies)\n\nExclusion Criteria:\n\n* Cholesterol \\>300mg\u002Fdl\n* HbA1c \\>12 mg\u002Fdl\n* Previous amputation or debridement of vascular ulcers\n* Diagnosed varicose veins\n* History of SEPS(subfacial endoscopic perforator surgery)\n* Active bleeding disorder\n* Recent major surgery (\\\u003C1 month)\n* Renal failure requiring dialysis\n* Coagulopathy\n* Pregnancy or breastfeeding","ALL","40 Years","70 Years",{"count":79,"type":80},78,"ESTIMATED","INTERVENTIONAL",[83],"EARLY_PHASE1","The goal of this \\*\\*clinical trial\\*\\* is to compare the effectiveness of \\*\\*low-dose rivaroxaban plus aspirin versus aspirin alone\\*\\* in patients aged 40-70 years with \\*\\*chronic limb-threatening ischemia, diabetes mellitus, hypertension, and hypercholesterolemia\\*\\*. The main questions it aims to answer are:\n\n* Does low-dose rivaroxaban plus aspirin reduce \\*\\*major adverse limb events (MALE)\\*\\*, such as acute limb ischemia and amputation?\n* Does the combination therapy reduce \\*\\*major adverse cardiovascular events (MACE)\\*\\*, such as myocardial infarction and stroke, and improve limb-related outcomes?\n\nResearchers will compare \\*\\*low-dose rivaroxaban (2.5 mg twice daily) plus aspirin (75-100 mg daily)\\*\\* with \\*\\*aspirin alone\\*\\* to see if combination therapy provides better outcomes over a period of \\*\\*6 months\\*\\*.\n\nParticipants will:\n\n* Undergo baseline clinical assessment, blood tests, ABPI\u002FTBI, and Doppler\u002Fduplex assessment.\n* Be randomly assigned to either the rivaroxaban plus aspirin group or the aspirin-alone group.\n* Attend follow-up visits at specified intervals for assessment of \\*\\*WIFI score, ABPI, wound healing, MALE, MACE, and quality of life\\*\\*.\n* Be assessed for treatment compliance, side effects, and bleeding during follow-up.",[86],"Limb Ischemia",[88,89],"aspirin","Low-Dose Rivaroxaban","2026-09-18",{"date":92,"type":93},"2026-09-22","ACTUAL",{"date":95,"type":93},"2026-06-01",{"date":97,"type":80},"2027-04-01",{"name":5,"class":6},1]