Demographic Outcomes, and Health Care Resources in Newly Diagnosed Non Valvular AF Patients

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.

Study Overview

• Status: Unknown
• Conditions: Non Valvular AF ,AF

• Study Type: Observational
• Enrollment (Anticipated): 84

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71511
    • Recruiting
    • Assiut University
    • Contact: hossam hassan, professor; Phone Number: 01223971327; Email: hossam_hassan@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
● Stroke: hemorrhagic or ischemic; ● Transient Ischemic Attack (TIA); ● Systemic embolism; ● Bleeding events (see definitions and categories below); ● Myocardial infarction; ● All-cause mortality.	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:; Intracranial;; Intra-spinal;; Intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed);; Pericardial;; Intra-articular;; Intramuscular with compartment syndrome;; Retroperitoneal.; Bleeding that is fatal.	6 monthes

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (ACTUAL): October 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: non valvular AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: demographic base line , medical history clinical picture and complications treatment compliance follow up hospital admission and health resources
• IPD Sharing Time Frame: 3 years
• IPD Sharing Access Criteria: demographic base line , medical history clinical picture and complications treatment compliance follow up hospital admission and health resources
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No