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
ID Number 15-2023Principal Investigator(s)
Department(s) or Division(s)
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 cardiovascular events (e.g., stroke or heart attack) after a person with vessel disease in their legs has had a revascularization procedure to improve blood flow. Rivaroxaban is currently approved by some Health Authorities as a treatment to reduce the risk of blood clots. Aspirin (also known as ASA) is 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 revascularization procedure to reduce the risk of blood clots that can lead to a cardiovascular event, such as a stroke or heart attack. This study will test to see if taking rivaroxaban with aspirin will have a better effect in preventing these kinds of events.
Volunteers may qualify to take part in this research study if they have had a procedure to improve blood flow called revascularization (e.g., stent or surgical bypass) in one of their lower limbs to treat their Peripheral Artery Disease (PAD).
Recruiting Patients: Yes