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Completed

NCT Number: NCT04234698

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site

Bogota, Cundinamarca, 111211, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Time to Diagnose NVAF by Each OAC Treatment

    Time frame: 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.

  2. Number of Participants With Comorbidities

    Time frame: 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.

  3. Number of Participants With Uncontrolled Hypertension at OAC Prescription Date

    Time frame: 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.

  4. Number of Participants With Use of Aspirin at Start OAC Treatment

    Time frame: 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.

  5. Number of Participants With Use of Clopidogrel at Start of OAC Treatment

    Time frame: 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.

  6. Number of Participants With Use of Non-Steroidal Anti-Inflammatory Drugs at Start of OAC Treatment

    Time frame: 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.

  7. HAS-BLED Score at Start of OAC Treatment

    Time frame: 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.

  8. CHA2DS2-VASc Score at Start of OAC Treatment

    Time frame: 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.

  9. Number of Participants With Anemia at Start of OAC Treatment

    Time frame: 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.

  10. Number of Participants With Stroke

    Time frame: 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.

  11. Duration of Follow-up in Participants With Stroke

    Time frame: 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.

  12. Number of Participants According to Type of Stroke

    Time frame: 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.

  13. Number of Participants With Pulmonary Embolism

    Time frame: 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.

  14. Duration of Follow-up in Participants With Pulmonary Embolism

    Time frame: 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.

  15. Number of Participants With Gastrointestinal Bleeding

    Time frame: 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.

  16. Duration of Follow-up in Participants With Gastrointestinal Bleeding

    Time frame: 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.

  17. Number of Participants With Intracranial Bleeding

    Time frame: 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.

  18. Duration of Follow-up in Participants With Intracranial Bleeding

    Time frame: 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.

  19. Number of Deaths

    Time frame: 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.

  20. Duration of Follow-up in Participants Who Died

    Time frame: 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.

  21. Time Under OAC Treatment (Persistence) by Each OAC Treatment

    Time frame: 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.

  22. Number of Participants With Other Major Bleeding

    Time frame: 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.

  23. Duration of Follow-up in Participants With Other Major Bleeding

    Time frame: 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.

  24. Dose of Initial OAC Prescription by Each OAC Treatment

    Time frame: 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.

  25. Number of Doses Dispensed at Initial OAC Treatment by Each OAC Treatment

    Time frame: 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.

  26. Number of Participants With Dose Reduction by Each OAC Treatment

    Time frame: 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.

  27. Time to Dose Reduction by Each OAC Treatment

    Time frame: 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.

  28. Number of Participants With Treatment Discontinuation

    Time frame: 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.

  29. Time to Discontinuation

    Time frame: 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.

  30. Number of Participants According to Reasons for Discontinuation

    Time frame: 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.

  31. Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)

    Time frame: 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.

  32. Number of Participants Who Switched to Another OAC Treatment

    Time frame: 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.

  33. Time to Switch to Another OAC Treatment

    Time frame: 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.

  34. Number of Participants According to Reasons for Switching OAC Treatment

    Time frame: 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.

  35. Number of Participants With Concomitant Therapies by OAC Prescription

    Time frame: 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.

  36. Number of Participants Who Were Previously Exposed to Warfarin (NOACs Group Only)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 21, 2020
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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