GLORIA-AF Registry Program (Phase I)

Tracking Information
First Submitted Date	August 25, 2011
First Posted Date	September 5, 2011
Results First Submitted Date	January 21, 2014
Results First Posted Date	March 5, 2014
Last Update Posted Date	March 5, 2014
Study Start Date	May 2011
Actual Primary Completion Date	January 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: January 21, 2014)	CHADS2 Score [ Time Frame: Baseline ]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 ]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 ]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 ]; Gender [ Time Frame: Baseline ]; Age Group [ Time Frame: Baseline ]; Medical History [ Time Frame: Baseline ]; Concomitant Medication [ Time Frame: Baseline ]
Original Primary Outcome Measures; (submitted: September 2, 2011)	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 ]; Gender [ Time Frame: 1 day ]; Age Group [ Time Frame: 1 day ]
Change History	Complete list of historical versions of study NCT01428765 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	GLORIA-AF Registry Program (Phase I)
Official Title	GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase I)
Brief Summary	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.
Detailed Description	Study Design: cross-sectional
Study Type	Observational
Study Design	Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	adult patients with non-valvular atrial fibrillation at risk for stroke
Condition	Atrial Fibrillation
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	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.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: April 17, 2013)	1096
Original Estimated Enrollment; (submitted: September 2, 2011)	8000
Actual Study Completion Date	January 2013
Actual Primary Completion Date	January 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion criteria: 1) Patients newly diagnosed with non-valvular atrial fibrillation at risk for stroke. Exclusion criteria: 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 oral anticoagulant treatment (vitamin K antagonist) (VKA) in their lifetime;; Atrial fibrillation (AF) with a generally reversible cause;; Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (VKAs) is indicated
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	China, Croatia, Egypt, Germany, Lebanon, Netherlands, Spain, Turkey
Removed Location Countries	El Salvador, Venezuela
Administrative Information
NCT Number	NCT01428765
Other Study ID Numbers	1160.114
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Boehringer Ingelheim
Study Sponsor	Boehringer Ingelheim
Collaborators	Not Provided
Investigators	Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account	Boehringer Ingelheim
Verification Date	January 2014