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Clinical Trial Details

Trial ID: L1705
Source ID: NCT06606275
Associated Drug: Apixaban
Title: The Safety and Effectiveness of Warfarin Vs Apixaban in Patients with NVAF/ VTE and ESKD on Dialysis
Acronym: WARD
Status: COMPLETED
Study Results: NO
Results:
Conditions: End-Stage Kidney Disease (ESKD)|Non-valvular Atrial Fibrillation (NVAF)|Venous Thromboembolism (VTE)
Interventions: DRUG: Apixaban|DRUG: Warfarin
Outcome Measures: Primary: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Safety will be assessed by Major/Minor bleeding incidents based on International Society on Thrombosis and Haemostasis (ISTH) criteria, From date of enrollment until the date of first bleeding event or date of death from any cause, whichever came first, assessed up to 6 months|Effectiveness: VTE, Effectiveness will be measured by VTE events based on documented radiography and/or wells score for PE/DVT, From date of enrollment until the date of first documented VTE event or date of death from any cause, whichever came first, assessed up to 6 months|Effectiveness: Stroke, The primary outcome is the occurrence of stroke events in the study population, confirmed through clinical evaluation (e.g., neurological assessment) and imaging (CT or MRI). Data will be collected and reported as the number of patients experiencing stroke events during the study period. The incidence will be further categorized by stroke type (ischemic or hemorrhagic) and the severity of the event, using the National Institutes of Health Stroke Scale (NIHSS) for assessment. Aggregated data will include the total number of stroke events, time to occurrence, and any associated patient outcomes (e.g., mortality, disability)., From date of enrollment until the date of first documented Stroke event or date of death from any cause, whichever came first, assessed up to 6 months | Secondary: Dose appropriateness, This measure will evaluate the dose appropriateness of apixaban and warfarin in patients with end-stage kidney disease (ESKD) on dialysis. For apixaban, dose appropriateness will be assessed based on FDA dosing guidelines for patients with renal impairment, including dosage adjustments for specific clinical factors (e.g., age, weight, and concurrent medications). For warfarin, dose appropriateness will be evaluated using the target International Normalized Ratio (INR) range for stroke prevention or VTE management. The data will be aggregated and reported as the number and percentage of patients receiving guideline-concordant doses. In cases where dosing is not appropriate, discrepancies will be documented and analyzed., Up to 6 months
Sponsor/Collaborators: Sponsor: Abu Dhabi Health Services Company | Collaborators: United Arab Emirates University|Cleveland Clinic Abu Dhabi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 67
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-11-05
Results First Posted:
Last Update Posted: 2024-11-05
Locations: SEHA Tawam Hospital, Al Ain, Abu Dhabi, United Arab Emirates
URL: https://clinicaltrials.gov/show/NCT06606275