Association between statin treatment and cardiovascular outcomes in patients with atrial fibrillation

Lead Investigator: George Ntaios, University of Thessaly
Title of Proposal Research: Association between statin treatment and cardiovascular outcomes in patients with atrial fibrillation
Vivli Data Request: 8720
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Atrial fibrillation (also called AFib or AF) is an irregular heartbeat (arrhythmia) that begins in the heart’s upper chambers (atria). It can lead to blood clots, stroke, heart failure and other heart-related complications. It is estimated that 12.1 million people in the United States will have AFib in 2030. There is increasing evidence suggesting that statin treatment improves cardiovascular outcomes in patients with AF. Statins are a class of lipid-lowering medications and are the most common cholesterol-lowering drugs. However, the quality of this evidence is not high. This meta-analysis aims to pool individual patient data from two randomized controlled trials (ENGAGE-AF and RE-LY) in patients with atrial fibrillation to investigate this question This will provide further evidence about the rols of statin treatment in patients with AF, and promote further research in this field.

Requested Studies:

A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation – Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE – AF TIMI – 48)
Data Contributor: Daiichi Sankyo
Study ID: NCT00781391
Sponsor ID: DU176b-C-U301

Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)
Data Contributor: Boehringer Ingelheim
Study ID: NCT00262600
Sponsor ID: 1160.26