Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation
NCT02007655
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Patients who are beginning to receive the treatment with this product under the approved indications, dosage, and administration will be included in this study
- Patients who are receiving Eliquis outside of its approved indication will be excluded
from this study
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Descriptive Information | ||||
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Brief Title | Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation | |||
Official Title | Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation | |||
Brief Summary | The primary objectives of this study are:
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Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | University hospitals, general hospitals, and clinics that have relevant departments, such as cardiology, cerebrovascular medicine, neurology, internal medicine, neurosurgery, etc, where the surveillance drug is mainly prescribed | |||
Condition | NonValvular Atrial Fibrillation | |||
Intervention | Drug: Eliquis
Other Names:
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Study Groups/Cohorts | Eliquis on Nonvalvular Atrial Fibrilliation patients
Patients who are beginning to receive the treatment with Eliquis under the approved indications, dosage, and administration will be included in this study Intervention: Drug: Eliquis | |||
Publications * | Inoue H, Umeyama M, Yamada T, Hashimoto H, Komoto A, Yasaka M. Safety and effectiveness of reduced-dose apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A sub-analysis of the STANDARD study. J Cardiol. 2020 Feb;75(2):208-215. doi: 10.1016/j.jjcc.2019.07.007. Epub 2019 Aug 15. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment | 5500 | |||
Original Estimated Enrollment | Same as current | |||
Estimated Study Completion Date | December 31, 2020 | |||
Estimated Primary Completion Date | August 17, 2020 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT02007655 | |||
Other Study ID Numbers | CV185-286 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Bristol-Myers Squibb | |||
Study Sponsor | Bristol-Myers Squibb | |||
Collaborators | Pfizer | |||
Investigators |
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PRS Account | Bristol-Myers Squibb | |||
Verification Date | January 2019 |