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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ischaemic heart diseases
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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
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
History of previous MI • Presentation with cardiac arrest • Cardiogenic shock (defined as systolic blood pressure <90 mmHg for >30minutes,or necessitating vasopressors to achieve a blood pressure ≥90 mmHg) • Cardiac electrical instability (defined as complete heart block needing temporary pacing or any tachyarrhythmia needing cardioversion) • Patients with Killip class III heart failure • History of severe chronic renal failure (define as stage 4 (GFR = 15-29 mL/min) or worse) • History of hepatitis B,HIV or tuberculosis • Patient positive for point of care bedside test of Ag HBs • Severe,progressive infections documented Active COVID-19 infection or COVID-19 infection within 3 months • Patient with documented severe immune deficiency • Presence,or history in ≤ five years,of an ongoing cancer,(except in situ cancer of the cervix or basal cell carcinoma) • QTcF> 450 msecs in males,> 470msecs in females • Any oral or intravenous immunosuppressive treatment,immune modulatory monoclonal antibodies or immunodepleting therapy at any time (inhalers and topical creams with corticosteroids are permitted) • Previous history of major organ transplant including renal transplant • Known hypersensitivity to the active substance of MabThera® (rituximab) or to proteins of murine origin,or to any of the other excipients • Any contraindications to any of the Mabthera® premedication drugs • Contraindications to injectable Polaramine: o Risk of closed-angle glaucoma,o Risk of urinary retention linked to urethroprostatic disorders. • Expected need for vaccination with a live attenuated vaccine during the study,including incomplete vaccination courses (in case,life,attenuated vaccine must be administered at least 30 days before inclusion in study) • Absence of a complete COVID-19 vaccination scheme (including recovery from documented COVID infection) as approved at the time of enrolment in the country where the patient is recruited Any obvious contraindications for MRI or conditions which will impede image acquisition for example: o Severe claustrophobia o Non-MRI compatible permanent pacemaker o Patients who have a metallic foreign body (metal sliver) in their eye,or who have an aneurysm clip in their brain o Patients who have had metallic devices placed in their back o Known hypersensitivity to imaging products (gadoteric acid,meglumin or any drug containing gadolinium) • Known hepatic failure Previous history of progressive multifocal leukoencephalopathy • Inclusion in other interventional drug study within the previous 3 months • Inability to comply with study procedures • Patients under guardianship or curatorship
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (APHP) (France) and funded by European Commission .
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for Trial ID: CPMS 56763
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