Clinical trial NCT04234698: Patient Characteristics, Treatment Patterns And Incidence Of Events (Discontinuation, Persistence, Key Primary Clinical Outcomes) In NVAF Patients Initiating OAC Therapy In Colombia
Official title: Patient Characteristics, Treatment Patterns and Incidence of Events (Discontinuation, Persistence, Key Primary Clinical Outcomes) in NVAF Patients Initiating OAC Therapy in Colombia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: oral anticoagulants
apixaban
rivaroxaban
dabigatran
warfarin
non valvular atrial fibrillation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-01-21
Enrollment: 2076
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Time to Diagnose NVAF by Each OAC Treatment
timeFrame: At index date (anytime between 01-January-2013 to 30-June-2018)
measure: Number of Participants With Comorbidities
timeFrame: 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)
measure: Number of Participants With Uncontrolled Hypertension at OAC Prescription Date
timeFrame: At index date (any time between 01-January-2013 to 30-June-2018)
measure: Number of Participants With Use of Aspirin at Start OAC Treatment
timeFrame: At index date (anytime between 01-January-2013 to 30-June-2018)
measure: Number of Participants With Use of Clopidogrel at Start of OAC Treatment
timeFrame: At index date (anytime between 01-January-2013 to 30-June-2018)
measure: Number of Participants With Use of Non-Steroidal Anti-Inflammatory Drugs at Start of OAC Treatment
timeFrame: At index date (anytime between 01-January-2013 to 30-June-2018)
measure: HAS-BLED Score at Start of OAC Treatment
timeFrame: At index date (anytime between 01-January-2013 to 30-June-2018)
measure: CHA2DS2-VASc Score at Start of OAC Treatment
timeFrame: At index date (anytime between 01-January-2013 to 30-June-2018)
measure: Number of Participants With Anemia at Start of OAC Treatment
timeFrame: At index date (anytime between 01-January-2013 to 30-June-2018)
measure: Number of Participants With Stroke
timeFrame: 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)
measure: Duration of Follow-up in Participants With Stroke
timeFrame: 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)
measure: Number of Participants According to Type of Stroke
timeFrame: 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)
measure: Number of Participants With Pulmonary Embolism
timeFrame: 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)
measure: Duration of Follow-up in Participants With Pulmonary Embolism
timeFrame: 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)
measure: Number of Participants With Gastrointestinal Bleeding
timeFrame: 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)
measure: Duration of Follow-up in Participants With Gastrointestinal Bleeding
timeFrame: 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)
measure: Number of Participants With Intracranial Bleeding
timeFrame: 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)
measure: Duration of Follow-up in Participants With Intracranial Bleeding
timeFrame: 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)
measure: Number of Deaths
timeFrame: 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)
measure: Duration of Follow-up in Participants Who Died
timeFrame: 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)
measure: Time Under OAC Treatment (Persistence) by Each OAC Treatment
timeFrame: 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)
measure: Number of Participants With Other Major Bleeding
timeFrame: 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)
measure: Duration of Follow-up in Participants With Other Major Bleeding
timeFrame: 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)
measure: Dose of Initial OAC Prescription by Each OAC Treatment
timeFrame: At index date (anytime between 01-January-2013 to 30-June-2018)
measure: Number of Doses Dispensed at Initial OAC Treatment by Each OAC Treatment
timeFrame: At index date (anytime between 01-January-2013 to 30-June-2018)
measure: Number of Participants With Dose Reduction by Each OAC Treatment
timeFrame: 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)
measure: Time to Dose Reduction by Each OAC Treatment
timeFrame: 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)
measure: Number of Participants With Treatment Discontinuation
timeFrame: 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)
measure: Time to Discontinuation
timeFrame: 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)
measure: Number of Participants According to Reasons for Discontinuation
timeFrame: 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)
measure: Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)
timeFrame: From 1 Month to maximum 6.5 years (Jan 2013 to Jul 2019)
measure: Number of Participants Who Switched to Another OAC Treatment
timeFrame: 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)
measure: Time to Switch to Another OAC Treatment
timeFrame: 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)
measure: Number of Participants According to Reasons for Switching OAC Treatment
timeFrame: 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)
measure: Number of Participants With Concomitant Therapies by OAC Prescription
timeFrame: 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)
measure: Number of Participants Who Were Previously Exposed to Warfarin (NOACs Group Only)
timeFrame: Up to 6 months prior to index date
Secondary outcomes:
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: