Clinical trial NCT04110197: Demographic Outcomes, and Health Care Resources in Newly Diagnosed Non Valvular AF Patients
Official title: Demographic Outcomes, and Health Care Resources in Newly Diagnosed Non Valvular AF Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Valvular AF ,AF
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective observational study to be carried out in Assiut University Heart Hospital.

The study is designed to capture real-world evidence (RWE) on patients' characteristics and the clinical management of patients with with NVAF vs VAF. All consecutive patients that are newly diagnosed with NVAF within the recruitment period (estimated to be 6 months) and 90 days before baseline visit and who meet the study inclusion/exclusion criteria will be invited to participate in the study. The study periods may be revised based on recruitment rate.

Brief summary: 1. 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.
2. To describe the clinical outcomes (stroke/systemic embolism, bleeding complications, as well as cause-specific and all-cause mortality) with NVAF vs VAF.
3. 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.
4. 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.


Eligibility criteria: Inclusion Criteria:

* 1. All male or female patients aged 18 years and older at the date of inclusion.

  2. Patient newly diagnosed \[within the recruitment period (estimated to be 6 months) and 90 days before the baseline visit\] with atrial fibrillation (AF) and for whom treatment has started by the caring physician for the prevention of stroke/systemic embolism.

  3. Signed informed consent.

Exclusion Criteria:

* 2. Severe psychiatric illness or other disease or circumstances that could compromise participation in the study. Patients will not be enrolled if major difficulties with follow-up will be anticipated, for example, patients with no valid residency permit or those planning to leave the country before the next scheduled follow-up.

  3. Current participation in an interventional clinical trial at baseline. 4. AF with a generally reversible cause defined as non-cardiac surgery, post-cardiac surgery (AF within 3 months after surgery), hyperthyroidism, pulmonary embolism, pneumonia and acute myocardial infarction.

  5. Mechanical heart valves or valve disease expected to require valve replacement.

  6. A medical condition other than AF for which chronic use of VKA/NOAC is indicated.

  7. Pregnant or breast-feeding women. Pregnancy to be ruled out according normal practice method of each site.

Primary outcomes:
measure: ● Stroke: hemorrhagic or ischemic; ● Transient Ischemic Attack (TIA); ● Systemic embolism; ● Bleeding events (see definitions and categories below); ● Myocardial infarction; ● All-cause mortality.
timeFrame: 6 monthes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References: