RITA-MI 2

• Research type

  Research Study

• Full title

  Rituximab in patients with ST-elevation myocardial infarction. A phase 2 placebo-controlled randomized clinical trial

• IRAS ID

  1006054

• Contact name

  Sophie Courtial-Destembert

• Contact email

  sophie.courtial-destembert@aphp.fr

• Sponsor organisation

  ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

• Eudract number

  2021-003340-24

• Clinicaltrials.gov Identifier

  NCT05211401

• Research summary

  Ischemic heart disease is the first cause of mortality worldwide and is associated with important morbidity, reduced quality of life, and a huge economic cost. Myocardial infarction (MI), which is also commonly known as heart attack, is a medical emergency where the heart muscle is damaged due to restricted heart flow, and as a result, its cells begin to die through necrosis. In this process, white blood cells called B lymphocytes are activated to target the myocardial cells. It is estimated that up to one in five patients still experience recurrent cardiovascular events after acute myocardial infarction, 50% of patients show cardiac dysfunction and a substantial proportion of these patients go on to develop overt heart failure. Therefore, limiting myocardial necrosis is an important clinical goal.
  In fact, preliminary animal studies have shown a potential benefit of a drug called Rituximab in MI. By binding to the CD20 protein, it reduces the number of mature B lymphocytes and the extent of the infarction. Thus, the purpose of this study is to explore whether this beneficial effect would be the same in humans.
  RITA-MI 2 is a randomised clinical trial that evaluates the efficacity of Rituximab in reducing the extent of the infarction and the functioning of the heart, by measuring the left ventricular ejection fraction (LVEF = percentage of blood that the left ventricle can eject with each beat). Patients aged from 18 to 75 regardless the gender, presenting symptoms as clinical evidence for anterior ST-elevation myocardial infarction (STEMI), are invited to participate. They will have a follow-up of 12 months and the total duration of the research is expected to be 58 months. It is hypothesised that the treatment will improve the LVEF after STEMI, thereby reducing the risk of recurrent ischemic events, and eventually heart failure

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  22/EE/0294

• Date of REC Opinion

  9 May 2023

• REC opinion

  Further Information Favourable Opinion