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

Patient Characteristics, Treatment Patterns and Incidence of Events (Discontinuation, Persistence, Key Primary Clinical Outcomes) in NVAF Patients Initiating OAC Therapy in Colombia

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation

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.

• Study Type: Observational
• Enrollment (Actual): 207

Contacts and Locations

Study Locations

• Colombia
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 111211
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The total population of patients treated with any oral anticoagulant between January 1, 2013 and June 30, 2018 will be analyzed in the claim database. This means that patients who start warfarin and NOACs would be included within this period. Patients who initiate NOACs within the established period and who have been exposed to warfarin before 2013 will also be included.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage distribution of clinical and demographic characteristics	Demographic (age, sex, race, and geographical distribution) and clinical (BMI, comorbidities, HASBLED,CHAD2DS2-VAC, NVAF time) characteristic will be measured according to report in medical records at baseline	Baseline
Percentage of use of OACs	It includes frequency of use per OACs describing the dosage, discontinuation and persistence	Baseline up to ocurrence of discontinuation, switch of treatment, death or first event of stroke/ systemic embolism, major bleeding event, death or end of follow-up, whichever came first , assessed up to 156 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of Stroke/ Systemic Embolism	Incidence rate will be calculated by the number of first event of stroke/systemic embolism from baseline until the ocurrence of discontinuation, switch of treatment, death or first event of stroke/ systemic embolism, major bleeding event, death or end of follow-up divided by patient-months estimated by calculating all of the months that patients were exposed to OACs during follow up.The ICD-10 codes relative to these events will be used to identified the events in medical records	Baseline up to ocurrence of discontinuation, switch of treatment, death or first event of stroke/ systemic embolism, major bleeding event, death or end of follow-up, whichever came first , assessed up to 156 weeks
Incidence rate of major bleeding	Incidence rate will be calculated by the number of first event of major bleeding from baseline until the ocurrence of discontinuation, switch of treatment, death or first event of stroke/ systemic embolism, major bleeding event, death or end of follow-up divided by patient-months estimated by calculating all of the months that patients were exposed to OACs during follow up.The ICD-10 codes relative to these events will be used to identified the events in medical records	Baseline up to ocurrence of discontinuation, switch of treatment, death or first event of stroke/ systemic embolism, major bleeding event, death or end of follow-up, whichever came first , assessed up to 156 weeks

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 22, 2021
• Primary Completion (ACTUAL): May 31, 2021
• Study Completion (ACTUAL): May 31, 2021

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (ACTUAL): January 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: oral anticoagulants; warfarin; rivaroxaban; apixaban; dabigatran; non valvular atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: B0661148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No