CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 300 enrolled
Drug / intervention
Interrupted apixaban +1 moredrug
Likely dose
Not stated in 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/NCT02608099
NCT02608099Phase 4Completed

Apixaban Evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation

Baim Institute for Clinical Research·interventional·Posted Nov 18, 2015·Updated Mar 17, 2020

In Brief

A Phase 4 clinical trial evaluating Interrupted apixaban and Uninterrupted apixaban for Atrial Fibrillation. Completed, enrolled 300 participants across 19 sites.

Detailed Summary

The purpose of the prospective, randomized cohort in this study is to assess the safety and efficacy of 2 apixaban treatment strategies (uninterrupted versus interrupted) in subjects planned to undergo catheter ablation for the treatment of non-valvular atrial fibrillation (NVAF). Simultaneously, a retrospective cohort of 300 warfarin-treated individuals, identified by chart review, who are matched to the prospective randomized subjects, will be identified. The purpose of the retrospective warfarin cohort is to compare the efficacy and safety of warfarin(the current clinical practice) to that of apixaban (uninterrupted, interrupted, combined uninterrupted and interrupted).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 18, 2015
Enrollment StartNov 1, 2015
Primary CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.6 years ago

Interventions

Interrupted apixabandrug

Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.

Uninterrupted apixabandrug

Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.