Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation
NCT02007655
Last updated date
ABOUT THIS STUDY
The primary objectives of this study are:
- To estimate the incidence rate of unexpected adverse events
- To characterize the bleeding events and assess risk factors of bleeding
- To identify ancillary baseline variables that may also be associated with adverse
outcomes
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
NonValvular Atrial Fibrillation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Patients who are beginning to receive the treatment with this product under the approved indications, dosage, and administration will be included in this study
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Patients who are receiving Eliquis outside of its approved indication will be excluded
from this study
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NonValvular Atrial FibrillationEliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation
NCT02007655
- Toyama-shi, Toyama
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| 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:
| |||
| 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:
| |||
| 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:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Bristol-Myers Squibb | |||
| Verification Date | January 2019 | |||