N/A Completed N=2,076

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

Atrial Fibrillation

Source: ClinicalTrials.gov NCT04234698 ↗

Enrolled (actual)

2,076

Serious AEs

4.1%

Results posted

Feb 2025

Primary outcomePrimary: Time to Diagnose NVAF by Each OAC Treatment — 71; 324; 218; 406 Days

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Diagnose NVAF by Each OAC Treatment	71; 324; 218; 406	—
PRIMARY Number of Participants With Comorbidities	100; 370; 5; 25; 386; 1430	—
PRIMARY Number of Participants With Uncontrolled Hypertension at OAC Prescription Date	19; 50	—
PRIMARY Number of Participants With Use of Aspirin at Start OAC Treatment	191; 660	—
PRIMARY Number of Participants With Use of Clopidogrel at Start of OAC Treatment	37; 133	—
PRIMARY Number of Participants With Use of Non-Steroidal Anti-Inflammatory Drugs at Start of OAC Treatment	18; 50	—
PRIMARY HAS-BLED Score at Start of OAC Treatment	2.25; 1.99	—
PRIMARY CHA2DS2-VASc Score at Start of OAC Treatment	3.6; 3.6	—
PRIMARY Number of Participants With Anemia at Start of OAC Treatment	62; 217	—
PRIMARY Number of Participants With Stroke	56; 263	—
PRIMARY Duration of Follow-up in Participants With Stroke	244; 680	—
PRIMARY Number of Participants According to Type of Stroke	11; 45; 5; 2	—
PRIMARY Number of Participants With Pulmonary Embolism	1; 5	—
PRIMARY Duration of Follow-up in Participants With Pulmonary Embolism	25; 620	—
PRIMARY Number of Participants With Gastrointestinal Bleeding	19; 23	—
PRIMARY Duration of Follow-up in Participants With Gastrointestinal Bleeding	501; 444	—
PRIMARY Number of Participants With Intracranial Bleeding	5; 2	—
PRIMARY Duration of Follow-up in Participants With Intracranial Bleeding	400; 206	—
PRIMARY Number of Deaths	1; 5	—
PRIMARY Duration of Follow-up in Participants Who Died	881; 722	—
PRIMARY Time Under OAC Treatment (Persistence) by Each OAC Treatment	440; 491; 364; 608	—
PRIMARY Number of Participants With Other Major Bleeding	17; 19	—
PRIMARY Duration of Follow-up in Participants With Other Major Bleeding	233; 585	—
PRIMARY Dose of Initial OAC Prescription by Each OAC Treatment	4.5; 17.9; 7.8; 239	—
PRIMARY Number of Doses Dispensed at Initial OAC Treatment by Each OAC Treatment	5; 20; 10; 220	—
PRIMARY Number of Participants With Dose Reduction by Each OAC Treatment	0; 375; 173; 159	—
PRIMARY Time to Dose Reduction by Each OAC Treatment	68.5; 479; 523; 324	—
PRIMARY Number of Participants With Treatment Discontinuation	78; 147	—
PRIMARY Time to Discontinuation	332; 463	—
PRIMARY Number of Participants According to Reasons for Discontinuation	4; 4; 2; 3; 5; 12	—
PRIMARY Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)	54; 56; 53; 44; 34; 21	—
PRIMARY Number of Participants Who Switched to Another OAC Treatment	194; 151	—
PRIMARY Time to Switch to Another OAC Treatment	2309.0; 1114.0	—
PRIMARY Number of Participants According to Reasons for Switching OAC Treatment	2; 16; 0; 3; 7; 5	—
PRIMARY Number of Participants With Concomitant Therapies by OAC Prescription	305; 641; 270; 186; 266; 598	—
PRIMARY Number of Participants Who Were Previously Exposed to Warfarin (NOACs Group Only)	181	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04234698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.