GLORIA-AF Registry Program - Second and Third Phases

Completed

Conditions studied: Stroke, Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01468701

Run by

Boehringer Ingelheim

People needed

37235

Starts

2011-11-07

Expected to finish

2020-01-10

Last updated by the study team

2021-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Black Warrior Research — Northport, Alabama, United States
• Scottsboro Quick Care Clinic — Scottsboro, Alabama, United States
• Alaska Heart Institute — Anchorage, Alaska, United States
• Phoenix Heart PLLC — Glendale, Arizona, United States
• Mercy Cinic Hot Springs Communities — Hot Springs, Arizona, United States
• Midwest Internal Medicine, PLLC — Lake Havasu City, Arizona, United States
• Sparks Regional Medical Center — Fort Smith, Arkansas, United States
• Dr. Michael A. Frais, Cardiologist, P.A. — Hot Springs, Arkansas, United States
• Cardiology and Medicine Clinic — Little Rock, Arkansas, United States
• Donald W. Reynolds Institute on Aging — Little Rock, Arkansas, United States
• Arkansas Cardiology, PA — Little Rock, Arkansas, United States
• Diagnamics, Inc — Encinitas, California, United States
• Allianz Medical and Research Center — Fountain Valley, California, United States
• B&K Medical Research Center — Fresno, California, United States
• American Clinical Trials — Hawaiian Gardens, California, United States
• Scripps Clinic — La Jolla, California, United States
• La Mesa Cardiac Center — La Mesa, California, United States
• Los Alamitos Cardiovascular — Los Alamitos, California, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• Mehrdad Kevin Ariani, MD, Incorporated — Northridge, California, United States
• VA Palo Alto Health Care System — Palo Alto, California, United States
• Eisenhower Desert Cardiology Center — Rancho Mirage, California, United States
• Ritchken and First MD's — San Diego, California, United States
• Coastal Heart Group Inc — Santa Ana, California, United States
• University South Alabama Medical Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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