GLORIA-AF Registry Program (Phase I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01428765
First received: August 25, 2011
Last updated: January 21, 2014
Last verified: January 2014

August 25, 2011
January 21, 2014
May 2011
January 2013   (final data collection date for primary outcome measure)
  • CHADS2 Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    CHADS2 score is based on a point system in which 2 points are assigned for a history of stroke or transient ischemic attack and 1 point each is assigned for age equal to or greater more than 75 years, hypertension, diabetes, or clinical heart failure or impaired left ventricular systolic function (generally interpreted as an ejection fraction ≤ 40%).
  • CHA2DS2-VASc Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The CHA2DS2-VASc risk score is based on a point system in which 2 points are assigned for a history of stroke or TIA, or age ≥75; and 1 point each is assigned for age 65-74 years, a hypertension, diabetes, cardiac failure, vascular disease and female sex. On the basis of the risk strata defined in previous guidelines, a CHA2DS2-VASc score of 0 corresponds to "low risk", a score of 1 corresponds to "intermediate risk", and a score of 2 or more corresponds to "high risk".
  • HAS-BLED Risk Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The HAS-BLED score is based on a point system in which 1 point is assigned for hypertension (systolic blood pressure >160 mmHg), 1 point for each of abnormal renal (presence of chronic dialysis or renal transplantation or serum creatinine ≥200 μmol/L) and liver (chronic hepatic disease or biochemical evidence of significant hepatic derangement) function, 1 point each is assigned for stroke, bleeding (previous bleeding history and/or predisposition to bleeding), labile Internation Normalized Ratios (INRs,unstable/high INRs or poor time in therapeutic range), age >65 years and 1 point each for drugs (such as antiplatelet agents, non-steroidal anti-inflammatory drugs) or alcohol.
  • Antithrombotic Treatment Choice at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Gender [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Age Group [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Medical History [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Concomitant Medication [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Antithrombotic treatment choice at baseline [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Gender [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Age group [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • 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 ]
Complete list of historical versions of study NCT01428765 on ClinicalTrials.gov Archive Site
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GLORIA-AF Registry Program (Phase I)
GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase I)

This study constitutes Phase I of the Registry Program. The main objective of this study is to characterize the newly diagnosed non-valvular AF patient population at risk for stroke and the selection of antithrombotic treatment for stroke prevention in a real-world setting before dabigatran etexilate is approved for the prevention of strokes and systemic emboli in patients with non-valvular AF in different regions of the world.

Study Design:

cross-sectional

Observational
Time Perspective: Cross-Sectional
Not Provided
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Non-Probability Sample

adult patients with non-valvular atrial fibrillation at risk for stroke

Atrial Fibrillation
Not Provided
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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.
 
Completed
1096
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

1) Patients newly diagnosed with non-valvular atrial fibrillation 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 oral anticoagulant treatment (vitamin K antagonist) (VKA) in their lifetime;
  3. Atrial fibrillation (AF) with a generally reversible cause;
  4. Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (VKAs) is indicated
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Croatia,   Lebanon,   China,   Turkey,   Egypt,   Netherlands,   Spain,   Germany
 
NCT01428765
1160.114
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
January 2014

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