N/A
Completed N=37,235
GLORIA-AF Registry Program - Second and Third Phases
Source: ClinicalTrials.gov NCT01468701 ↗Enrolled (actual)
37,235
Serious AEs
6.0%
Results posted
Mar 2021
Primary outcomePrimary: Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II — 2.06 Events per 100 person-years
Summary
In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II |
2.06 | — |
| PRIMARY Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase III |
2.21; 3.23 | — |
| PRIMARY Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase II |
1.74 | — |
| PRIMARY Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase III |
1.91; 2.62 | — |
| PRIMARY Incidence Rate of Stroke or Systemic Embolism - Phase III |
0.80; 1.00 | — |
| PRIMARY Incidence Rate of Stroke - Phase II |
0.65 | — |
| PRIMARY Incidence Rate of Stroke - Phase III |
0.77; 0.96 | — |
| PRIMARY Incidence Rate of Transient Ischaemic Attack (TIA) - Phase II |
0.21 | — |
| PRIMARY Incidence Rate of Transient Ischaemic Attack (TIA) - Phase III |
0.29; 0.32 | — |
| PRIMARY Incidence Rate of Systemic Embolism (SE) - Phase II |
0.04 | — |
| PRIMARY Incidence Rate of Systemic Embolism (SE) - Phase III |
0.04; 0.05 | — |
| PRIMARY Incidence Rate of Pulmonary Embolism (PE) - Phase II |
0.07 | — |
| PRIMARY Incidence Rate of Pulmonary Embolism (PE) - Phase III |
0.07; 0.06 | — |
| PRIMARY Incidence Rate of Major Bleeding Events (MBE) - Phase II |
0.97 | — |
| PRIMARY Incidence Rate of Major Bleeding Events (MBE) - Phase III |
0.69; 1.44 | — |
| PRIMARY Incidence Rate of Life-threatening Bleeding Events - Phase II |
0.46 | — |
| PRIMARY Incidence Rate of Life-threatening Bleeding Events - Phase III |
0.47; 1.07 | — |
| PRIMARY Incidence Rate of Myocardial Infarction (MI) - Phase II |
0.50 | — |
| PRIMARY Incidence Rate of Myocardial Infarction (MI) - Phase III |
0.40; 0.53 | — |
| PRIMARY Incidence Rate of All-cause Death - Phase II |
2.48 | — |
| PRIMARY Incidence Rate of All-cause Death - Phase III |
2.16; 3.57 | — |
| PRIMARY Incidence Rate of Vascular Death - Phase II |
0.85 | — |
| PRIMARY Incidence Rate of Vascular Death - Phase III |
0.75; 1.26 | — |
Eligibility Criteria
Inclusion criteria
- Age =>18 years at enrollment
- Male or female patient (or legally acceptable representative) willing and able to provide written informed consent
- Patient newly diagnosed (< 3 months prior to baseline visit) with non-valvular AF and at risk for stroke.
Other inclusion criteria apply.
Exclusion criteria
- Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;
- Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime;
- AF with a generally reversible cause;
- Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a VKA) is indicated Other exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT01468701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.