GLORIA-AF Registry Program (Phase I)
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| ClinicalTrials.gov Identifier: NCT01428765 |
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Recruitment Status :
Completed
First Posted : September 5, 2011
Results First Posted : March 5, 2014
Last Update Posted : March 5, 2014
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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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.
| Condition or disease |
|---|
| Atrial Fibrillation |
| Study Type : | Observational |
| Actual Enrollment : | 1096 participants |
| Time Perspective: | Cross-Sectional |
| Official Title: | GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase I) |
| Study Start Date : | May 2011 |
| Actual Primary Completion Date : | January 2013 |
| Actual Study Completion Date : | January 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
Primary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
adult patients with non-valvular atrial fibrillation at risk for stroke
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428765
Locations
Show 62 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01428765 |
| Other Study ID Numbers: |
1160.114 |
| First Posted: | September 5, 2011 Key Record Dates |
| Results First Posted: | March 5, 2014 |
| Last Update Posted: | March 5, 2014 |
| Last Verified: | January 2014 |
Additional relevant MeSH terms:
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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |