Trial intelligence / Profile preview

OVID RAF: Oral vs IV Diltiazem in AF

NCT03472495Phase 4

Key facts

Status
Completed
Start
Jun 2018
Primary completion
Mar 2021
Countries
1
Sponsor
Virginia Commonwealth University
Modality
Small Molecules
Conditions
Atrial fibrillation (AFib)atrial flutter (AFL)
01

Overview

Phase 4, randomised, open-label trial of diltiazem in Atrial fibrillation (AFib) and atrial flutter (AFL) (2 arms), sponsored by Virginia Commonwealth University. Primary endpoint: Heart Rate Control at 2 hours. Started Jun 2018; status: completed.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Oral Immediate Release Diltiazem

    Diltiazem immediate release 60mg orally once

  • Continuous Infusion IV Diltiazem

    Diltiazem 2.5-5 mg/hour intravenous Titrate

03

Who it enrols

Adult patients with atrial fibrillation or flutter and a heart rate > 110 beats/min, excluding those with hypotension, pregnancy, WPW syndrome, or prior antiarrhythmic use.

04

Endpoints

Primary

  • Heart Rate Control

Secondary

  • Adverse Event Rate

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