Clinical trial NCT02007655: Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation
Official title: Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NonValvular Atrial Fibrillation
Keywords: Cardiovascular
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2013-12-11
Enrollment: 6372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief summary: 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


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* 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:

* Patients who are receiving Eliquis outside of its approved indication will be excluded from this study

Primary outcomes:
measure: Incidence rate of unexpected adverse events
timeFrame: Day 1 (At Eliquis initiation)
measure: Incidence rate of unexpected adverse events
timeFrame: 12 weeks after initiation
measure: Incidence rate of unexpected adverse events
timeFrame: 52 weeks after initiation
measure: Incidence rate of unexpected adverse events
timeFrame: 104 week (discontinuation)
measure: Bleeding events and risk factors of bleeding
timeFrame: Day 1 (At Eliquis initiation)
measure: Bleeding events and risk factors of bleeding
timeFrame: 12 weeks after initiation
measure: Bleeding events and risk factors of bleeding
timeFrame: 52 weeks after initiation
measure: Bleeding events and risk factors of bleeding
timeFrame: 104 week (discontinuation)
measure: Ancillary baseline variables that may also be associated with adverse outcomes
timeFrame: Day 1 (At Eliquis initiation)
measure: Ancillary baseline variables that may also be associated with adverse outcomes
timeFrame: 12 weeks after initiation
measure: Ancillary baseline variables that may also be associated with adverse outcomes
timeFrame: 52 weeks after initiation
measure: Ancillary baseline variables that may also be associated with adverse outcomes
timeFrame: 104 week (discontinuation)
Secondary outcomes:
Other outcomes:
Locations:
city: Toyama-shi
country: Japan
facility: Local Institution
state: Toyama
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.