GLORIA-AF: Global Registry on Long-term Oral Anti-thrombotic Treatment in Patients with Atrial Fibrillation

Study ID
STU 052012-086

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Clements University Hospital

Contact
Anne Leyretana-Zabat
714/507-8089
anne.leyretana-zabat@utsouthwestern.edu

Principal Investigator
Richard Wu

Summary

GLoRia-aF Phase ii/iii is part of a global, multi-center, prospective Registry Program investigating patients with newly diagnosed non-valvular aF at risk for stroke (defined as a CHa2DS2-VaSc stroke risk score of at least 1); Phase i (data collection before approval of dabigatran) of this Registry Program is described elsewhere. Phase ii/iii is outlined in 2 separate protocols.
Phase ii, which is planned to be initiated after approval of dabigatran in the respective country, consists of baseline visit and two-year follow-up for patients treated with dabigatran for prevention of stroke. Patients enrolled in Phase ii initially receiving other oral anticoagulants than dabigatran (e.g. VKas) or antithrombotic therapy, or no therapy for stroke prevention, will only participate in the baseline visit without participation in any subsequent follow-up visits.
Before initiation of Phase iii regular interim analyses will be conducted during Phase ii on patients initiating dabigatran and those initiating VKa at baseline visit to evaluate the similarity of pts in these 2 groups. once comparability regarding important baseline (known risk factors for stroke and bleeding such as age, gender, hypertension, diabetes mellitus, prior stroke, prior transient ischemic attack, and prior bleeding) of these groups has been established and likely amount of residual channeling bias after confounder adjustment is comparatively small, Phase iii will be initiated. The main measure to determine comparability of the 2 treatment groups regarding their important baseline characteristics will be the overlap on the propensity score, as measured by the proportion of patients in region of overlap of the propensity score. The decision to start with Phase iii will be region specific. Patients already enrolled in Phase ii will complete their visit schedule as planned. each patient enrolled into GLoRia-aF can only participate in one phase, i.e. those patients enrolled into Phase ii are not eligible to participate in Phase iii.
in Phase iii all newly diagnosed non-valvular aF patients will be followed up for 3 years regardless of antithrombotic therapy treatment status. The main comparison of interest is comparison of dabigatran vs VKa. However, potential other pair-wise comparisons may be conducted as further analyses, given comparability of these treatment groups regarding important baseline characteristics. The interim analyses to compare the baseline characteristics of patients initiating dabigatran or VKas will be continued during Phase iii, in order to address the potential changing relevance of VKas. Further comparisons of drugs may be added in order to reflect the possible approval of other new oral anticoagulants. it could turn out that Phase iii cannot be conducted; i.e. if after 2 years of assessing baseline characteristics of dabigatran and VKa initiators in Phase ii comparability has not been achieved, which would preclude any meaningful comparisons, then a comparative data collection will not be started.
Phase ii/iii data will be collected in up to 60 countries in up to about 2200 sites and is planned to involve as many as 6000 or more investigators from regions all over the world. Five regions are defined: 1) asia/ australia, 2) europe, 3) north america, 4) Latin america and 5) africa/ Middle east (for planned participating countries per region).
inclusion of participating centers in registry will be based on the goal to represent the proportion of patients treated within different health care settings of pespective country. in total, an enrolment goal of approximately 16000 patients is planned for Phase ii and another 32000 patients for Phase iii. The planned registry period is from July 2011 to June 2020, which covers the total expected duration of Phase ii and iii.
enrollment into Phase iii of the study will end after the overall enrollment goal has been met, or by June 2017, whichever comes first. individual regions may end earlier depending on recruitment.

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. 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. registry phase.