About this trial
VKA in RHD patients with MHV: our current status
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed presence of a mechanical heart valve.
Aged ≥18 years
Disqualifiers
Pregnancy.
Active bleeding disorders.
Severe liver/kidney disease (if affecting anticoagulation).
Trial population
Data collection: Data will be collected directly by the researcher and will be reviewed by the supervising team to ensure accuracy and consistency. The data collection process will involve recording INR observation , clinical evaluations Each participant will have their data entered into a secure database for further analysis.
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Time in therapeutic range (TTR) for warfarin.
TTR status will be calculated using the most recent INR value and patient records to determine whether INR is within the target therapeutic range (2.0-3.5) at the time of data collection.
2. Correlation Between TTR and Patient-Specific Factors
Assesses the relationship between INR control and factors such as age, comorbidities, adherence, vitamin K intake, and medication use based on data collected at the single study visit.
Secondary outcomes
1. Number of Participants With Reported Bleeding Events (Major or Minor)
Presence or absence of self-reported or documented major/minor bleeding events prior to or at the time of data collection.
Number of Participants With Thromboembolic Events
History of stroke, valve thrombosis, or systemic embolism collected from medical records or patient report during the study visit.
Rate of Patient Adherence to Warfarin Therapy
Adherence assessed via patient self-report and/or pill count at the single study visit.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ahmed Hassan Rostom Ibrahim
Lead sponsor
Assiut University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: