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GLORIA-AF Registry Program (Phase I)

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ClinicalTrials.gov Identifier: NCT01428765
Recruitment Status : Completed
First Posted : September 5, 2011
Results First Posted : March 5, 2014
Last Update Posted : March 5, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Time Perspective: Cross-Sectional
Condition Atrial Fibrillation
Enrollment 1096
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 1063
Completed 1063
Not Completed 0
Arm/Group Title All Patients
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 1063
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1063 participants
68.2  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1063 participants
Female
486
  45.7%
Male
577
  54.3%
1.Primary Outcome
Title CHADS2 Score
Hide Description 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%).
Time Frame Baseline
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
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[Not Specified]
Overall Number of Participants Analyzed 1063
Measure Type: Number
Unit of Measure: participants
Low (Score=0) 102
Moderate (Score=1) 386
High (Score >=2) 575
2.Primary Outcome
Title CHA2DS2-VASc Score
Hide Description 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”.
Time Frame Baseline
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[Not Specified]
Arm/Group Title All Patients
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[Not Specified]
Overall Number of Participants Analyzed 1063
Measure Type: Number
Unit of Measure: participants
Low (Score=0) 0
Moderate (Score=1) 226
High (Score >=2) 837
3.Primary Outcome
Title HAS-BLED Risk Score
Hide Description 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.
Time Frame Baseline
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[Not Specified]
Arm/Group Title All Patients
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[Not Specified]
Overall Number of Participants Analyzed 1063
Measure Type: Number
Unit of Measure: participants
Low (Score <3) 860
High (Score >=3) 121
Missing 82
4.Primary Outcome
Title Antithrombotic Treatment Choice at Baseline
Hide Description [Not Specified]
Time Frame Baseline
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[Not Specified]
Arm/Group Title All Patients
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[Not Specified]
Overall Number of Participants Analyzed 1063
Measure Type: Number
Unit of Measure: participants
None 215
Vitamin K Antagonist (VKA) 349
Acetylsalicylic Acid (ASA) 443
Antiplatelet agents other than ASA 36
Other 20
5.Primary Outcome
Title Gender
Hide Description [Not Specified]
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
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[Not Specified]
Arm/Group Title All Patients
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[Not Specified]
Overall Number of Participants Analyzed 1063
Measure Type: Number
Unit of Measure: participants
Female 486
Male 577
6.Primary Outcome
Title Age Group
Hide Description [Not Specified]
Time Frame Baseline
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[Not Specified]
Arm/Group Title All Patients
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[Not Specified]
Overall Number of Participants Analyzed 1063
Measure Type: Number
Unit of Measure: participants
<65 years 382
65 to <75 years 314
>= 75 years 367
7.Primary Outcome
Title Medical History
Hide Description [Not Specified]
Time Frame Baseline
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[Not Specified]
Arm/Group Title All Patients
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[Not Specified]
Overall Number of Participants Analyzed 1063
Measure Type: Number
Unit of Measure: participants
Previous stroke 110
Coronary artery disease (CAD) 256
Congestive heart failure 256
History of hypertension 795
Diabetes mellitus 240
8.Primary Outcome
Title Concomitant Medication
Hide Description [Not Specified]
Time Frame Baseline
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[Not Specified]
Arm/Group Title All Patients
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[Not Specified]
Overall Number of Participants Analyzed 1063
Measure Type: Number
Unit of Measure: participants
Antihypertensive/heart failure and antiarrhythmic 739
Metabolic and anti-inflammatory therapy 395
Time Frame 1 day
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
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All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   0/1063 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%)
Total   0/1063 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01428765     History of Changes
Other Study ID Numbers: 1160.114
First Submitted: August 25, 2011
First Posted: September 5, 2011
Results First Submitted: January 21, 2014
Results First Posted: March 5, 2014
Last Update Posted: March 5, 2014