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Early Post-Marketing Study of ELIQUIS (Apixaban) in Mexico

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ClinicalTrials.gov Identifier: NCT02345343
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The primary objective of the study is to report adverse events of on-treatment AEs by the treating physicians during a specified 24-month study period in patients with venous thromboembolism at the sentinel site(s) for the National Center of Pharmacovigilance (CNFV) in Mexico.

Condition or disease Intervention/treatment
Deep Vein Thrombosis Pulmonary Embolism Drug: Apixaban

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Post-Marketing Study of Eliquis (Apixaban), in Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and Prevention of Recurrent DVT and PE in Adults
Actual Study Start Date : May 4, 2015
Actual Primary Completion Date : October 7, 2015
Actual Study Completion Date : October 7, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Group/Cohort Intervention/treatment
Drug: Apixaban
Patients with VTE who are being given apixaban for the treatment and/or prevention of recurrence of DVT and PE at the sentinel site
Drug: Apixaban
Other Name: Eliquis




Primary Outcome Measures :
  1. The number of adverse events (AEs) notified to health authorities (HAs) of on-treatment AEs by the treating physicians [ Time Frame: Up to 24-month study period ]

Secondary Outcome Measures :
  1. The AEs reported to HA in a table format identifying the report number, patient ID number, and type of AE [ Time Frame: Up to 24-month study period ]


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:

  • Patients 18 years old with DVT and PE at the sentinel site who received at least 1 dose of apixaban for the treatment and/or prevention of recurrence of DVT and PE 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 approved
  • Contraindications included in the approved Mexican prescribing information

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): NCT02345343


Locations
Mexico
Local Institution
Queretaro, Mexico, 76000
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02345343     History of Changes
Other Study ID Numbers: CV185-399
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants