Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05836987
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-04-19
Brief Title:
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
REACT-AF Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REACT-AF
Brief Summary:
REACT-AF is a multicenter prospective randomized open-label blinded endpoint PROBE design controlled trial comparing the current Standard Of Care SOC of continuous Direct Oral Anticoagulation DOAC use versus time-delimited 1 month DOAC guided by an AF-sensing Smart Watch AFSW in participants with a history of paroxysmal or persistent Atrial Fibrillation AF and low-to-moderate stroke risk
Detailed Description:
REACT-AF is a prospective unblinded randomized 11 allocation multi-center investigational clinical trial of men and women aged 22-85 with a documented history of symptomatic or asymptomatic paroxysmal or persistent AF and a moderate risk of stroke measured by CHA2DS2-VASc score 1-4 for men 2-4 for women which stands for Congestive heart failure Hypertension Age 75 doubled Diabetes Stroke doubled Vascular disease age 65 to 74 and sex category female Participants randomized to the experimental arm on demand DOAC will take the participants DOAC for 30 consecutive days following a qualifying AF episode ie greater than1 hour detected by the AFSW Participants randomized to the standard of care control arm will remain on previously prescribed continuous DOAC throughout the study
A total of 5350 participants will be enrolled across up to 100 study sites targeting two-thirds academic and one-third private practices with academic practices also enrolling from affiliated community sites The investigators anticipate evaluating 7643 consented individuals with external monitoring to ensure that a low AF burden population will be randomized Up to 200 participants may be enrolled at any one site and participation will last up to 60 months
A total of 5350 participants will be enrolled across up to 100 study sites targeting two-thirds academic and one-third private practices with academic practices also enrolling from affiliated community sites The investigators anticipate evaluating 7643 consented individuals with external monitoring to ensure that a low AF burden population will be randomized Up to 200 participants may be enrolled at any one site and participation will last up to 60 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U24HL165066-01 | NIH | None | httpsreporternihgovquickSearch1U24HL165066-01 |