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
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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Tracking Information | ||||
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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 |
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Original Primary Outcome Measures |
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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 |
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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. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
1096 | |||
Original Estimated Enrollment |
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:
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Sex/Gender |
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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 |
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PRS Account | Boehringer Ingelheim | |||
Verification Date | January 2014 |