NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT04234698

CompletedN/A

Sponsor: Pfizer

Conditions: Atrial Fibrillation

Countries: 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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (1)

Bogota, Cundinamarca, Colombia