Blood clots in the heart (left ventricular [LV] thrombus) are a complication of large heart attacks and other causes of severely reduced heart muscle function. Although less frequent nowadays, due to better treatments for heart attacks, LV thrombus remains relatively common. Despite this there is no good quality evidence on which to decide the best treatment and very limited data on the outcomes of patients who are affected. The Resolution of Left Ventricular thrombus [RELEVENT] trial and registry will address this evidence gap; combining the initial phase of a randomised clinical trial addressing early management with establishing an ongoing registry that will clarify the need for and design of further research.
The primary aim in the treatment of patients with LV thrombus is to reduce the risk of the clot traveling elsewhere, which can result in a stroke or other major tissue injury by abruptly occluding blood flow. To reduce this risk, the standard treatment is blood-thinning (anti-coagulation) with warfarin, but this is inconvenient and increases the risk of bleeding. Newer direct oral anticoagulants (DOACs) are easier for patients to use and in other conditions have been shown to be safer and more effective. There are, however, settings where warfarin remains the better treatment. The first phase of this work is, therefore, to establish the feasibility of the RELEVENT trial, which will test whether DOACs are as good as warfarin in the treatment of LV thrombus.
Patients who complete the RELEVENT trial, plus those who are ineligible, will be asked to consent to follow up in the RELEVENT registry. This will collect data regarding their ongoing treatment and medium to long-term outcomes. These data will determine the need for and design of further trials; for example, assessing the most appropriate management of patients with LV thrombus beyond 3 months.
Last updated12 July 2021