Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

NCT02007655 | Completed

• 1 other identifier: CV185-286
• Study Type: observational
• Target: 6,372
• Locations: 1 country
• Sites: 1

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

Conditions

NonValvular Atrial Fibrillation

Keywords

Cardiovascular

Outcome Measures

Primary Outcomes (12)

• Incidence rate of unexpected adverse events

  Day 1 (At Eliquis initiation)

• Incidence rate of unexpected adverse events

  12 weeks after initiation

• Incidence rate of unexpected adverse events

  52 weeks after initiation

• Incidence rate of unexpected adverse events

  104 week (discontinuation)

• Bleeding events and risk factors of bleeding

  Day 1 (At Eliquis initiation)

• Bleeding events and risk factors of bleeding

  12 weeks after initiation

• Bleeding events and risk factors of bleeding

  52 weeks after initiation

• Bleeding events and risk factors of bleeding

  104 week (discontinuation)

• Ancillary baseline variables that may also be associated with adverse outcomes

  Day 1 (At Eliquis initiation)

• Ancillary baseline variables that may also be associated with adverse outcomes

  12 weeks after initiation

• Ancillary baseline variables that may also be associated with adverse outcomes

  52 weeks after initiation

• Ancillary baseline variables that may also be associated with adverse outcomes

  104 week (discontinuation)

Study Arms (1)

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

Drug: Eliquis

Interventions

Eliquis DRUG

Also known as: Apixaban, BMS-562247

Eliquis on Nonvalvular Atrial Fibrilliation patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients who are beginning to receive the treatment with this product under the approved indications, dosage, and administration will be included in this study

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Pfizer: collaborator

Study Sites (1)

Local Institution

Toyama, Toyama, 930-0194, Japan

Location

Related Publications (1)

• 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.

  PMID: 31421933 DERIVED

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

apixaban

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 11, 2013
• Study Start: September 1, 2013
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2016
• Last Updated: June 7, 2022

Record last verified: 2022-06

Locations

JP (1)