Phase 3b AUGUSTUS study
Research type
Research Study
Full title
An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients with Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention
IRAS ID
182787
Contact name
Prof Robert Storey
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2014-002004-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 31 days
Research summary
Non-Valvular Atrial Fibrillation (AF) is a disease that causes the upper chambers of the heart to quiver rather than contract normally. AF may cause blood clots to form in the heart. Clots form when platelets stick together and proteins in the blood bind together to form a solid mass which can lead to a stroke or a heart attack.
Acute coronary syndrome (ACS) is a heart condition where blood supply to the heart is suddenly blocked; a procedure called Percutaneous Coronary Intervention (PCI) also known as angioplasty, is treatment for ACS that works to widen areas in the blood vessels where blood flow to the heart muscle has been reduced or blocked.
Bristol-Myers Squibb (BMS) & Pfizer Inc are conducting a clinical study on patients who have both conditions, AF and ACS (or have another medical reason for PCI). The study will compare two treatments, Apixaban against Warfarin.
The purpose of the study is to determine if apixaban is safer than usual care blood thinners in participants with non-valvular AF and ACS or PCI in relation to bleeding. “Usual care blood thinners” are (vitamin K antagonists: a group of drugs including Warfarin). This study will also evaluate if treatment with apixaban or Warfarin and a P2Y12 inhibitor alone is safer than treatment of apixaban or Warfarin with a combination of a P2Y12 inhibitor and Aspirin.
Approximately 4600 participants will be enrolled in this study. Around 150 participants will be recruited from 14 UK sites with participation expected to be 7 months.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0384
Date of REC Opinion
18 Nov 2016
REC opinion
Further Information Favourable Opinion