Demographic Outcomes, and Health Care Resources in Newly Diagnosed Non Valvular AF Patients
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|ClinicalTrials.gov Identifier: NCT04110197|
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
- To describe the patterns of care of newly diagnosed patients with NVAF vs VAF in the first-line, second-line and beyond second line setting, including, treatment plan, regimen, dosing, duration of treatment, and reason for interruption and termination along with treatment switching at any point of treatment, regardless if the patients are considered of first line, second line or further within the treatments.
- To describe the clinical outcomes (stroke/systemic embolism, bleeding complications, as well as cause-specific and all-cause mortality) with NVAF vs VAF.
- To describe the values and distribution of International normalized ratio (INR) in patients who received VKAs and to assess the influence of Time in therapeutic range (TTR) and INR history on clinical outcomes (stroke/systemic embolism, bleeding complications) with NVAF vs VAF.
- To evaluate AF-related healthcare resource utilization and direct costs associated with the management of AF patients with NVAF vs VAF.
and To describe the baseline clinical and demographic characteristics as well as risk factors among patients newly diagnosed with NVAF versus VAF.
|Condition or disease|
|Non Valvular AF ,AF|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||84 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Demographic Outcomes, and Health Care Resources in Newly Diagnosed Non Valvular AF Patients|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||December 1, 2021|
- ● Stroke: hemorrhagic or ischemic; ● Transient Ischemic Attack (TIA); ● Systemic embolism; ● Bleeding events (see definitions and categories below); ● Myocardial infarction; ● All-cause mortality. [ Time Frame: 6 monthes ]
- Acute clinically overt bleeding accompanied by one or more of the following:
- A decrease in hemoglobin (Hgb) of 2 g/dL or more over a 24-hour period;
- A transfusion of 2 or more units of packed red blood cells.
- Bleeding that occurs in at least one of the following critical sites:
- Intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed);
- Intramuscular with compartment syndrome;
- Bleeding that is fatal.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110197
|Assiut, Egypt, 71511|
|Contact: hossam hassan, professor 01223971327 email@example.com|