Early Post-Marketing Study of ELIQUIS (Apixaban) in Mexico | NCT02345343

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

NCT02345343

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jun 28, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Deep Vein Thrombosis
Pulmonary Embolism

Interventions

Apixaban

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 4, 2015Actual

Primary Completion Date

Oct 7, 2015Actual

Completion Date

Oct 7, 2015Actual

First Submitted Date

Jan 16, 2015

First Submission Date that Met QC Criteria

Jan 20, 2015

First Posted Date

Jan 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2017

Last Update Posted Date

Jun 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Apixaban	Drug		Drug: Apixaban	Eliquis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of adverse events (AEs) notified to health authorities (HAs) of on-treatment AEs by the treating physicians		Up to 24-month study period

Secondary Outcomes

Measure	Description	Time Frame
The AEs reported to HA in a table format identifying the report number, patient ID number, and type of AE		Up to 24-month study period

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The sentinel site for the CNFV in Mexico

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Querétaro		76000	Mexico

Label	URL
BMS Clinical Trial Patient Recruiting	View source

Condition Browse Module

MeSH Terms

ID	Term
D020246	Venous Thrombosis
D011655	Pulmonary Embolism

Ancestor Terms

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C522181	apixaban

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided