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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04234698
• Other study ID #: B0661148
• Status: Completed
• Start date: March 22, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: January 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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

External Links

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