CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 4,012 enrolled
Drug / intervention
Apixaban +1 moredrug
Likely dose
Apixaban 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01938248
NCT01938248Phase 4Completed
CompareCT.gov

Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation

Population Health Research Institute·interventional·Posted Sep 10, 2013·Updated Nov 15, 2023

In Brief

A Phase 4 clinical trial evaluating Apixaban and aspirin for Atrial Fibrillation and Stroke. Completed, enrolled 4,012 participants across 130 sites in 13 countries.

Detailed Summary

This study aims to determine if treatment with apixaban, compared with aspirin, will reduce the risk of ischemic stroke and systemic embolism in patients with device-detected sub-clinical atrial fibrillation and additional risk factors for stroke.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Stroke
CountriesBelgium, Canada, Czechia, Denmark, Germany, Hungary, Italy, Netherlands, Norway, Spain, Switzerland, United Kingdom, United States
CollaboratorsBristol-Myers Squibb, Pfizer, Medtronic, Canadian Institutes of Health Research (CIHR)

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 10, 2013
Enrollment StartMay 1, 2015
Primary CompletionOct 27, 2023
Study CompletionNov 3, 2023
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 12.8 years ago

Interventions

Apixabandrug

apixaban at a dose of 5 mg twice daily (2.5 mg twice daily if 2 or more of: age \> 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L)

aspirindrug

aspirin 81 mg once daily