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GLORIA-AF Registry Program - Second and Third Phases

This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01468701
First received: October 28, 2011
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  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 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.


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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]
  • Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • 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 ]
  • Transient Ischemic attack (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 ]
  • 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: 28000
Study Start Date: November 2011
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468701

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

  Show 473 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01468701     History of Changes
Other Study ID Numbers: 1160.129
Study First Received: October 28, 2011
Last Updated: May 15, 2013
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Brazil: Ministry of Health
Canada: Ethics Review Committee
Chile: Instituto de Salud Publica de Chile
China: Food and Drug Administration
Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Ecuador: Public Health Ministry
Egypt: Ministry of Health, Drug Policy and Planning Center
Hong Kong: Department of Health
Lebanon: Institutional Review Board
Mexico: Ministry of Health
Peru: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Saudi Arabia: Ministry of Health
Singapore: Clinical Trials and Epidemiology Research Unit (CTERU)
South Africa: Medicines Control Council
South Korea: Ministry of Food and Drug Safety (MFDS)
Taiwan: Institutional Review Board
Turkey: Ministry of Health
United Arab Emirates: Drug Cont Dept-Med&Pharm Cont-Ministry of Health
United States: Institutional Review Board
Venezuela:

Additional relevant MeSH terms:
Stroke
Atrial Fibrillation
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 May 23, 2013