GLORIA-AF Registry Program (Phase II/III)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01937377
First received: September 4, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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 three protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, 1160.136 for EU and EEA countries and 1160.171 for India and Switzerland. The total number of patients enrolled in three protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.


Condition
Stroke
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III-India and Switzerland)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • CHADS2 Score [cardiac failure, hypertension, age, diabetes, stroke (doubled)] [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • CHA2DS2-VASc Score [cardiac failure, hypertension, age >=75 (doubled), diabetes, stroke (doubled), vascular disease, age 65-74 and sex category (female) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • HAS-BLED score [hypertension, abnormal renal/liver function (1 point each), stroke, bleeding history or predisposition, labile International Normalized Ratio (INR), elderly (>65), drugs/alcohol concomitantly (1 point each)] [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Antithrombotic treatment choice at baseline [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Transient Ischemic Attach (TIA) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Systemic embolism [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Pulmonary embolism [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Life-threatening bleeding events [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Major bleeding events [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • All cause death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Non-vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Death of unknown cause [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Composite endpoint: stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2700
Study Start Date: September 2013
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with non-valvular AF

Criteria

Inclusion criteria:

1) Patients newly diagnosed with non-valvular atrial fibrillation (NVAF) at risk for stroke.

Exclusion criteria:

  1. Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;
  2. Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime;
  3. AF with a generally reversible cause;
  4. Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a VKA) is indicated.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01937377

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Switzerland
1160.171.44001 Boehringer Ingelheim Investigational Site Recruiting
Basel, Switzerland
1160.171.44006 Boehringer Ingelheim Investigational Site Recruiting
Basel, Switzerland
1160.171.44008 Boehringer Ingelheim Investigational Site Recruiting
Lausanne, Switzerland
1160.171.44002 Boehringer Ingelheim Investigational Site Recruiting
Lugano, Switzerland
1160.171.44004 Boehringer Ingelheim Investigational Site Recruiting
St. Gallen, Switzerland
1160.171.44005 Boehringer Ingelheim Investigational Site Recruiting
Urtenen-Schonbuhl, Switzerland
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01937377     History of Changes
Other Study ID Numbers: 1160.171
Study First Received: September 4, 2013
Last Updated: July 23, 2014
Health Authority: India: Drugs Controller General of India
Switzerland: Swissmedic

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014