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Early Post-marketing Study of Eliquis (Apixaban)

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ClinicalTrials.gov Identifier: NCT02153424
Recruitment Status : Withdrawn (Business objectives have changed.)
First Posted : June 3, 2014
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The primary objective of the study is to identify and describe any suspected (AEs) in all patients with NVAF treated with Apixaban, as a request of the National Center of Pharmacovigilance (CNFV) in Mexico.

Condition or disease Intervention/treatment
Non-valvular Atrial Fibrillation (NVAF) Drug: Apixaban

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Early Post-marketing Study of Eliquis (Apixaban)
Study Start Date : April 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Group/Cohort Intervention/treatment
NVAF patients in Mexico treated with Apixaban
All patients with NVAF at the sentinel site for the CNFV in Mexico who received at least 1 dose of Apixaban to reduce the risk of stroke or systemic embolism during the specified 24-month study period
Drug: Apixaban
Other Name: Eliquis




Primary Outcome Measures :
  1. Determine the reporting rate of on-treatment adverse events (AEs) by the treating physicians [ Time Frame: Up to 24 month study period ]
  2. Identify, describe, and report any suspected AEs that occur while on treatment with Apixaban or preventing stroke and systemic embolism in patients with NVAF [ Time Frame: Up to 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The sentinel site for the CNFV in Mexico
Criteria

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

Inclusion Criteria:

  • All patients with NVAF at the sentinel site for the CNFV in Mexico who received at least 1 dose of Apixaban to reduce the risk of stroke or systemic embolism during the specified 24-month study period

Exclusion Criteria:

  • Subjects who received Apixaban as part of a clinical trial
  • Subjects who received Apixaban for any indication other than local approval (ie, to reduce the risk of stroke and systemic embolism in patients with NVAF)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153424


Locations
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Mexico
Local Institution
Guadalajara, Jalisco, Mexico, 442003
Local Institution
Puebla, Mexico, 72040
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02153424     History of Changes
Other Study ID Numbers: CV185-330
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants