Efficacy and Safety of Oral Anticoagulants Among Thai Octogenarians With Nonvalvular Atrial Fibrillation

Stroke Clinical Trial

Official title:

Efficacy and Safety of Oral Anticoagulants Among Thai Octogenarians With Nonvalvular Atrial Fibrillation : A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04047654
• Other study ID #: NOACs in Thai Octogenarians
• Status: Completed
• Start date: April 22, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective cohort study of Thai octogenarians with nonvalvular atrial fibrillation (NVAF) initiating apixaban, dabigatran, rivaroxaban or warfarin was conducted in medical school hospital in Thailand. Patients were recruited from January 1, 2013, to December 31, 2018. The efficacy outcome was early recurrence of stroke or transient ischemic attack (TIA) in 90 days after initiation of oral anticoagulants (OACs). The safety outcome were major bleeding and clinically relevant non-major bleeding complications in 180 days. Continuous variables were compared using independent t test and MannWhitney U test, and categorical variables were compared using chi-square test or Fisher's exact test. Furthermore, hazard ratios and P values were calculated by the use of multivariable Cox's regression analysis.

Description:

This is a retrospective cohort study of Thai octogenarians with NVAF. Patients who were prescribed with apixaban, dabigatran, edoxaban, rivaroxaban or warfarin from January 1, 2013, to December 31, 2018 were recruited. The primary efficacy was recurrent ischemic stroke or TIA in 90 days after initiating OACs. The secondary efficacy were recurrent ischemic stroke or TIA in 180 days after initiating OACs. While any bleeding complications were defied as primary safety outcomes. Continuous variables were compared using independent t test and MannWhitney U test, and categorical variables were compared using chi-square test or Fisher's exact test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• Age more than 80 years old

• Patients who were diagnosed with I48, I63 or G45 from International Classification of Diseases 10th version (ICD-10). Patients who were diagnosed atrial fibrillation and flutter, cerebral infarction or transient cerebral ischemic attacks (TIA) and related syndromes)

• Patients were prescribed apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin

Exclusion Criteria:

• Patients were prescribed oral anticoagulants for other indications

1. Prophylaxis thromboembolic events in valvular atrial fibrillation

2. Treatment of venous thromboembolism

3. Prophylaxis thromboembolic events in hip or knee replacement

• Patients who had contraindication to oral anticoagulants

1. Creatinine clearance calculated from Cockcroft-Gault equation 1.1 Creatinine clearance less than 30 mL/min (for patients who receiving Dabigatran) 1.2 Creatinine clearance less than 15 (mL/min (for patients who receiving Apixaban, Edoxaban, Rivaroxaban)

2. Patients were diagnosed acute hepatitis, chronic active hepatitis

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Drug:
• Non vitamin K oral anticoagulants
Non vitamin K oral anticoagulants are apixaban, dabigatran, rivaroxaban, and edoxaban

Locations

Country	Name	City	State
Thailand	Siriraj Hospital, Phramongkutklao Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate recurrence of stroke or TIA in 90 days	Rate recurrence of stroke or TIA in 90 days after initiation of OACs	90 days after initiation of OACs
Secondary	Rate recurrence of stroke or TIA in 180 days	Rate recurrence of stroke or TIA in 180 days after initiation of OACs	180 days after initiation of OACs
Secondary	Rate of major bleeding	Rate of major bleeding in 90 days and 180 days after initiation of OACs	180 days after initiation of OACs
Secondary	Rate of clinically relevant non-major bleeding	Rate of clinically relevant non-major bleeding in 90 days and 180 days after initiation of OACs	180 days after initiation of OACs
Secondary	Patients's baseline characteristics associated with recurrence of stroke or TIA as assessed by multivariate cohort analysis	Patients's baseline characteristics associated with recurrence of stroke or TIA in 180 days after initiation of OACs as assessed by multivariate cohort analysis	180 days after initiation of OACs
Secondary	Patients's baseline characteristics associated with major bleeding and clinically relevant non-major bleeding as assessed by multivariate cohort analysis	Patients's baseline characteristics associated with major bleeding and clinically relevant non-major bleeding in 180 days as assessed by multivariate cohort analysis	180 days after initiation of OACs