Patient Characteristics, Treatment Patterns And Incidence Of Events (Discontinuation, Persistence, Key Primary Clinical Outcomes) In NVAF Patients Initiating OAC Therapy In Colombia

NCT ID: NCT04234698

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2076 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-22
• Study Completion Date: 2021-10-31

Brief Summary

The study aim to assess demographic and clinical characteristics , treatment patterns and as exploratory analysis will descriptively assess the time to clinical events of NVAF patients treated with oral anticoagulants (OACs) in Colombia through observational, descriptive study of a retrospective cohort of adult patients diagnosed with NVAF in selected Health Maintenance Organizations (HMO) of Colombia. The information will be used in the study comes exclusively form secondary sources: claim databases and medical records.

Detailed Description

The study has the following primary objectives:

• To assess demographic and clinical characteristics of NVAF patients treated with oral anticoagulants (OACs) in Colombia.
• To describe treatment patterns (eg OAC usage,dose, concomitant medications, persistance)

And as exploratory analysis to descriptively assess the time to clinical events (Effectiveness and Safety Outcomes) among patients persistent on OAC therapy

It is an observational, descriptive study of a retrospective cohort of adult patients diagnosed with NVAF in selected Health Maintenance Organizations (HMO) of Colombia. These patients will be identified from the drug claim database, whose index date of the study will be the first prescription with any of the oral anticoagulants, that is, they are patients with NVAF for the first time starting a therapy with any of the NOACs between January 1, 2013 and June 30, 2018 and follow up period will be among January 2013 to July 2019, to ensure that the last patients can provide follow-up for one year. Patients will be required to have an NVAF diagnosis before or on the index date and health plan for 6 months pre-index date (baseline period). Colombia. The information will be used in the study comes exclusively form secondary sources: claim databases and medical records.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients with a diagnosis of AF considered according to the following diagnoses as per the 10th revision of the International classification of diseases (ICD-10) I48 codes at some point before or on the index date, without recorded valvular disease;
• Patients who have started treatment with apixaban, dabigatran, rivaroxaban and warfarin for the first time during the identification period, understanding as start of drug delivery by insurer, and after the diagnosis of AF between January 1, 2013 to June 30, 2018;
• Patients starting apixaban, dabigatran, rivaroxaban from January 1, 2013 to June 30, 2018 in patients previously exposed to warfarin;
• Patient had continuous health plan enrolment for 6 months pre-index date (baseline period);
• Patients older than 18 years old on the index date;
• NVAF diagnosis before or on the index date.

Exclusion Criteria

• Patients with any of the following diagnoses prior to the use of the treatments of interest or index date:

• Valvular heart disease or valve replacement - ICD-10 codes: I05, I06, I07, I08, I09, I21, I22, I34, I35, I36, I37, I38, I39, I700, I702-I709; Q22, Q23, Q25, T82, Z95
• Pregnancy during the study period. ICD-10 O00-O9A
• Diagnosis of venous thromboembolism (VTE) - ICD-10 codes: I26, I80 - I82;
• Individuals with a transitory diagnosis of NVAF prior to the use of the treatments of interest or index date;
• Exposure to more than one OAC on or after the index date, during the follow-up period;
• NOAC doses different from those recommended by the manufacturing laboratories.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

Bogota, Cundinamarca, Colombia

Countries

Colombia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B0661148

To obtain contact information for a study center near you, click here.

Other Identifiers

B0661148

Identifier Type: -

Identifier Source: org_study_id