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GLORIA-AF Registry Program - Second and Third Phases

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01468701
First received: October 28, 2011
Last updated: March 27, 2017
Last verified: March 2017
October 28, 2011
March 27, 2017
November 2011
January 2020   (Final data collection date for primary outcome measure)
  • Myocardial infarction [ Time Frame: up to 3 years ]
  • Life-threatening bleeding events [ Time Frame: up to 3 years ]
  • All cause death [ Time Frame: up to 3 years ]
  • Vascular death [ Time Frame: up to 3 years ]
  • composite endpoint: Stroke, systemic embolism, myocardial infarction and vascular death (vascular composite endpoint) [ Time Frame: up to 3 years ]
  • Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ]
  • Transient Ischemic attack (TIA) [ Time Frame: up to 3 years ]
  • Systemic embolism [ Time Frame: up to 3 years ]
  • Pulmonary embolism [ Time Frame: up to 3 years ]
  • composite endpoint: stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death [ Time Frame: up to 3 years ]
  • Major bleeding events (including life-threatening bleeding events) [ Time Frame: up to 3 years ]
  • Myocardial infarction [ Time Frame: up to 3 years ]
  • Life-threatening bleeding events [ Time Frame: up to 3 years ]
  • Major bleeding events [ Time Frame: up to 3 years ]
  • All cause death [ Time Frame: up to 3 years ]
  • Non-vascular death [ Time Frame: up to 3 years ]
  • Death of unknown cause [ Time Frame: up to 3 years ]
  • vascular death [ Time Frame: up to 3 years ]
  • Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ]
  • Age Group [ Time Frame: 1 day ]
  • Gender [ Time Frame: 1 day ]
  • CHADS2 Score [cardiac failure, hypertension, age, diabetes, stroke (doubled)] [ Time Frame: 1 day ]
  • 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 ]
  • 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 ]
  • Antithrombotic treatment choice at baseline [ Time Frame: 1 day ]
  • Transient Ischemic attack (TIA) [ Time Frame: up to 3 years ]
  • Systemic embolism [ Time Frame: up to 3 years ]
  • Pulmonary embolism [ Time Frame: up to 3 years ]
  • composite endpoint: stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death [ Time Frame: up to 3 years ]
Complete list of historical versions of study NCT01468701 on ClinicalTrials.gov Archive Site
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GLORIA-AF Registry Program - Second and Third Phases
GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III)
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
patients with non-valvular AF
  • Stroke
  • Atrial Fibrillation
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Huisman MV, Lip GY, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Teutsch C, Zint K, Ackermann D, Clemens A, Bartels DB. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J. 2014 Mar;167(3):329-34. doi: 10.1016/j.ahj.2013.12.006. Epub 2013 Dec 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
19000
January 2020
January 2020   (Final data collection date for primary outcome measure)

Inclusion criteria:

  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 and at risk for stroke.

Other inclusion criteria apply.

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 Other exclusion criteria apply
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Canada,   Chile,   China,   Colombia,   Ecuador,   Hong Kong,   Japan,   Korea, Republic of,   Lebanon,   Mexico,   Peru,   Russian Federation,   Saudi Arabia,   Singapore,   South Africa,   Taiwan,   United Arab Emirates,   United States,   Venezuela
Croatia,   Puerto Rico,   Turkey
 
NCT01468701
1160.129
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Boehringer Ingelheim
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP