VOYAGER PAD
Research type
Research Study
Full title
An international, multicenter, randomized, double-blind, placebo-controlled phase 3 trial investigating the efficacy and safety of Rivaroxaban to reduce the risk of major thrombotic vascular events in patients with symptomatic peripheral artery disease undergoing lower extremity revascularization procedures
IRAS ID
181953
Contact name
Janice Tsui
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2014-005569-58
Duration of Study in the UK
3 years, 5 months, 1 days
Research summary
The purpose of this study is to find out about the safety and efficacy of rivaroxaban combined with aspirin in reducing the risk of major thrombotic vascular events (e.g., stroke or heart attack) after a person with Peripheral Artery Disease (PAD) had a revascularisation procedure at the lower limb (a procedure to improve blood flow e.g., stent or surgical bypass). Rivaroxaban is an novel oral anticoagulant approved by Health Authorities worldwide as a treatment to reduce the risk of blood clots. Aspirin (also known as ASA) is also approved by Health Authorities worldwide and is often used as a blood thinner to reduce the risk of blood clots.
Aspirin is usually prescribed after a revascularisation procedure to reduce the risk of blood clots that can lead to major thrombotic vascular events. This study will test to see if taking rivaroxaban with aspirin will have a better effect in preventing these kinds of events as compared to placebo and aspirin.
Rivaroxaban has not been approved by Health Authorities to prevent major thrombotic events following revascularisation procedures in PAD patients, and so it is considered investigational in this study.
About 6,500 people who have had a revascularisation procedure to treat PAD will take part in this study. Most patients in this study will complete a total of 8 visits over a period of two and a half years. Some patients may complete more or fewer visits over a longer or shorter length of time. Procedures will include blood samples, a test to measure blood pressure in the lower leg or foot using ultrasound (called Ankle or Toe Brachial Index), and answering questions about quality of life and walking capability. Approximately 500 medical centres in about 30 countries will be running the study.
Bayer HealthCare is funding the research.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
15/LO/1289
Date of REC Opinion
12 Sep 2015
REC opinion
Further Information Favourable Opinion