GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients with Atrial Fibrillation” (PHASE II/III)

Study ID
STU 062012-054

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System
  • UT Southwestern University Hospital– Zale Lipshy
  • UT Southwestern University Hospital—St. Paul

Contact
Atif Mohammad
214-857-1556
atif.mohammad@utsouthwestern.edu

Principal Investigator
Subhash Banerjee

Summary

GLORIA-AF is a multi center registry targeted at atrial fibrillation patient population on long-term oral antithrombotic treatment.
Objectives:

To investigate the patient characterisitics leading to oral antithrombotic treatment for prevention of stroke in atrial fibrillation.Also to collect real world data on the clinical outcomes of this specific patient population.
Methods:

Phase II and III of the study will be conducted at UTSW.
In Phase II (after the approval of dabigatran) there will be a
cross-sectional analysis at the patient[Right Quote]s baseline visit for all patients and a follow-up
for two years for patients initially treated with dabigatran.
In Phase III (given the comparability of the patient population prescribed either
dabigatran or vitamin K-antagonists) new patient recruitment will be started and after
the baseline visit all patients will be followed up for three years regardless of
antithrombotic therapy treatment status.
The baseline visit is defined as the physical visit when the patient is enrolled in the
registry.
Patients will either participate in Phase II or Phase III.

Diagnosis:

Patients newly diagnosed with non-valvular atrial fibrillation

Main criteria for inclusion:

Patients newly diagnosed with non-valvular atrial fibrillation (diagnosed and amp;lt; 3 months
before patient[Right Quote]s baseline visit) and at risk for stroke (CHA2DS2-VASc score of at
least 1), aged 18 years or older.Duration of follow up: 2 years for patients initiating dabigatran (Phase II); 3 years for all patients (Phase III) irrespective of anticoagulation treatment status

Outcomes:

Collect data on patient demographics, AF disease information, antithrombotic
treatment, medical history and concomitant medication at the patient[Right Quote]s baseline visit.
The patients will be followed for 2 (Phase II) and 3 years (Phase III) respectively and
information such as change in antithrombotic medication since previous visit
including compliance and occurrence of any outcome or safety events will be
captured. In Phase II follow-up information will be collected for those patients
initiating dabigatran, in Phase III for all patients.

Criteria for safety:
Serious adverse events, Acute drug reactions and major and life threatening bleeds.

Participant Eligibility

1. Age ≥18 years at enrollment
2. Male or female patient (or legally acceptable representative) willing and able to provide
written informed consent
3. Patient newly diagnosed (< 3 months prior to baseline visit) with non-valvular AF.
Documentation of AF by 12 lead ECG, ECG rhythm strip, pacemaker/ICD



electrocardiogram, or Holter ECG (duration of AF episode at least 30 seconds) needed for
all enrolled patients.
4. Patient must have a CHA2DS2-VASc score of at least 1 (see Table 10.1: 2). This requires
the presence of at least one of the following risk factors:
a. Congestive heart failure (NYHA Class 2 or greater) or moderate to severe LV systolic
dysfunction (e.g. LV EF ≤ 40%)
b. History of hypertension or systolic blood pressure >160mmHg
c. Diabetes mellitus
d. History of stroke, transient ischemic attack, or systemic embolism
e. Vascular disease defined as prior myocardial infarction, peripheral artery disease,
complex aortic plaque
f. Age ≥ 65
g. Female gender
Although AF diagnosis is a baseline requirement, patients are not required to have an
ongoing AF episode at the time of entry into this Registry Program.