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

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT04234698
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-21
• Study Start: 2021-03-22
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Results First Submitted: 2022-10-28
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Results First Posted: 2025-02-06
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2076

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Diagnose NVAF by Each OAC Treatment	At index date (anytime between 01-January-2013 to 30-June-2018)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants With Comorbidities	From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Participants classified according to the comorbidities they had were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. One participant may have more than one comorbidity.
Number of Participants With Uncontrolled Hypertension at OAC Prescription Date	At index date (any time between 01-January-2013 to 30-June-2018)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants With Use of Aspirin at Start OAC Treatment	At index date (anytime between 01-January-2013 to 30-June-2018)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants With Use of Clopidogrel at Start of OAC Treatment	At index date (anytime between 01-January-2013 to 30-June-2018)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants With Use of Non-Steroidal Anti-Inflammatory Drugs at Start of OAC Treatment	At index date (anytime between 01-January-2013 to 30-June-2018)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. In this study Aspirin was not considered as NSAID due to doses used in Colombia.
HAS-BLED Score at Start of OAC Treatment	At index date (anytime between 01-January-2013 to 30-June-2018)	The risk of bleeding in participants was assessed using Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile INR, Elderly, (age \>65 years), Drugs or alcohol (HAS-BLED) score. Score ranged from 0 to 8 with higher scores indicating greater risk of bleeding. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
CHA2DS2-VASc Score at Start of OAC Treatment	At index date (anytime between 01-January-2013 to 30-June-2018)	The CHA2DS2-VASc scale is an evaluation of stroke risk in participants with atrial fibrillation. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score , with total scores ranging from 0 to 9, with low scores indicating low risk for stroke, and high scores indicating high risk for stroke. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants With Anemia at Start of OAC Treatment	At index date (anytime between 01-January-2013 to 30-June-2018)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants With Stroke	From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Duration of Follow-up in Participants With Stroke	From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants According to Type of Stroke	From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Number of participants with type of stroke classified as either ischemic cerebrovascular event or hemorrhagic cerebrovascular event were reported in this outcome measure. Participants who reported cerebral infarction, stroke: not specified as hemorrhage or infarction in their medical history during the follow-up period were classified under ischemic cerebrovascular event and participants who reported subarachnoid hemorrhage, intracerebral hemorrhage and other nontraumatic intracranial hemorrhage in their medical record were classified under hemorrhagic stroke. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants With Pulmonary Embolism	From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	The number of participants who had pulmonary embolism were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Duration of Follow-up in Participants With Pulmonary Embolism	From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants With Gastrointestinal Bleeding	From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	The number of participants who had gastrointestinal bleeding were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Duration of Follow-up in Participants With Gastrointestinal Bleeding	From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants With Intracranial Bleeding	From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	The number of participants who had intracranial bleeding were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Duration of Follow-up in Participants With Intracranial Bleeding	From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Deaths	From index date until death or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Duration of Follow-up in Participants Who Died	From index date until death or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time Under OAC Treatment (Persistence) by Each OAC Treatment	From index date until switch of treatment, discontinuation, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Persistence was defined as the time under each OAC treatment, calculated as the time in days from the index date to the date of discontinuation or change of treatment. Participants were censored at the end of their follow-up period. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants With Other Major Bleeding	From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	The number of participants who had other major bleeding were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Duration of Follow-up in Participants With Other Major Bleeding	From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Dose of Initial OAC Prescription by Each OAC Treatment	At index date (anytime between 01-January-2013 to 30-June-2018)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Doses Dispensed at Initial OAC Treatment by Each OAC Treatment	At index date (anytime between 01-January-2013 to 30-June-2018)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants With Dose Reduction by Each OAC Treatment	From baseline (index date) until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Baseline was defined as the time of index date which was defined as the first prescription with any of the oral anticoagulants, that is, participants with NVAF for the first time starting a therapy with any of the NOACs between 01-Jan-2013 and 30-Jun-2018.
Time to Dose Reduction by Each OAC Treatment	From index date until date of dose reduction or until end of follow-up, anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants With Treatment Discontinuation	From index date until date of discontinuation, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Discontinuation was defined as the first day of a period of at least 30 consecutive days in which 0 days' supply for the index OAC was detected. The date of discontinuation was the end date of the last filled prescription before the treatment gap. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time to Discontinuation	From index date until date of discontinuation, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Time to discontinuation was defined as the number of days from the date of index oral anticoagulant prescription to the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants According to Reasons for Discontinuation	From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Discontinuation was defined as the first day of a period of at least 30 consecutive days in which 0 days' supply for the index OAC was detected. The date of discontinuation was the end date of the last filled prescription before the treatment gap. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)	From 1 Month to maximum 6.5 years (Jan 2013 to Jul 2019)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants Who Switched to Another OAC Treatment	From index date until switch of treatment or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	A switch among anticoagulants was defined as a prescription filled for non-index anticoagulants within +/- 30 days after the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time to Switch to Another OAC Treatment	From index date until switch of treatment or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	A switch among anticoagulants was defined as a prescription filled for non-index anticoagulants within +/- 30 days after the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants According to Reasons for Switching OAC Treatment	From index date until switch of treatment, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	A switch among anticoagulants was defined as a prescription filled for non-index anticoagulants within +/- 30 days after the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants With Concomitant Therapies by OAC Prescription	From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Number of Participants Who Were Previously Exposed to Warfarin (NOACs Group Only)	Up to 6 months prior to index date	Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇴 Bogota, Cundinamarca, Colombia