Extract

Background and study aims Optimal therapy for people who have had a stroke or a Transient Ischaemic Attack (TIA) consists of blood pressure (BP) lowering, cholesterol lowering and anti-platelet agents to reduce risk of further cerebrovascular events. Survey data continue to show that guidelines for secondary prevention of cardiovascular events are not well implemented in clinical practice. This is a worldwide phenomenon, more common in elderly patients. An alternative to traditional ‘treat to target’ approaches is to adopt simpler regimes such as using a fixed dose combination (FDC) pill. The aim of this study is to test whether such a regime will be non-inferior to standard care. The rationale for such a regime is that it will: reduce pill burden; ensure that all the key pharmacological therapies to lower cardiovascular risk after stroke are used; separate the decision to treat from the underlying level of the risk factor; and reduce monitoring burden (and costs). Evidence from trials in other populations, including people at high risk of cardiovascular disease and people with a history of myocardial infarction, suggests that such a regime is at least as effective as standard care. The purpose of this study is to determine whether an FDC pill has a role for secondary prevention of vascular events in older people who have had a stroke/TIA, in a primary care setting. Who can participate? Patients aged 55 years or over who have had a stroke or mini-stroke. What does the study involve? Following informed consent and initial health check, participants are randomly allocated into one of two groups. One group are given the polypill. The other group continue to receive standard care (separate antihypertensives and cholesterol lowering pills). Participants then have a follow-up health check at 6 months. After that, the study ends and participants on the polypill go back to standard care. What are the possible benefits and risks of participating? The risks of participating in this study are low. For participants treated with Trinomia, the risk of side effects are likely to be similar to those of the medicines they are taking already. Potential benefits for participants may include better management of risk factors for having another stroke. The results of the study may improve the future care of participants and other patients who have had a stroke. Where is the study run from? University of Cambridge (UK). When is the study starting and how long is it expected to run for? September 2015 to March 2018. Who is funding the study? British Heart Foundation (UK) and the Stroke Association (UK). Who is the main contact? Dr Merel Pannebakker [email protected]

Inclusion criteria

• Stroke Prevention

Links

• ictrp
• isrctn