Phase 2 Heart Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older (women must be either postmenopausal for more than 2 years with appropriate signs such as being over 55 with a history of hot flushes, or have had a hysterectomy and/or removal of both ovaries)
• People who are having a specific type of heart attack called an anterior STEMI, shown by symptoms of heart ischemia and a particular pattern on their heart tracing (ECG)
• People whose main heart artery (the left anterior descending artery) is found to be completely or almost completely blocked on an urgent angiogram (a scan of the heart's blood vessels)
• People whose heart attack symptoms began within 48 hours before the planned emergency procedure
• People whose blood test at admission shows a neutrophil count (a type of white blood cell) above 1.5 x 10⁹/L
• People whose blood test at admission shows a platelet count above 75 x 10⁹/L
• People for whom the treating team plans to perform an emergency procedure to open the blocked artery (primary PCI) within 2 hours of the ECG diagnosis
• People for whom the trial team is able to begin the study drug (rituximab) infusion within 3 hours of the emergency procedure
• People who are able to give written consent to participate

Who may not be able to join:

• People who have had a previous heart attack
• People who arrive having had a cardiac arrest
• People who are in cardiogenic shock (very low blood pressure that does not recover or requires medication to maintain)
• People with dangerous heart rhythm problems requiring emergency electrical treatment, or a complete blockage of the heart's electrical system requiring a temporary pacemaker
• People with a severe level of heart failure classified as Killip class III (confirm with trial site)
• People with a history of severe chronic kidney disease (stage 4 or worse, meaning the kidneys are working at a very low level)
• People with a history of hepatitis B, HIV, or tuberculosis
• People who test positive for hepatitis B on a bedside blood test at admission
• People with a serious, worsening active infection
• People with an active COVID-19 infection or who have had COVID-19 within the past 3 months
• People with a documented serious immune system deficiency
• People with a current or recent (within the last 5 years) cancer diagnosis (except early-stage cervical cancer or a type of skin cancer called basal cell carcinoma)
• People with a prolonged heart electrical interval on ECG (QTcF above 450ms in men or above 470ms in women)
• People who are currently taking or have ever taken any oral or intravenous immunosuppressive medications, immune-modifying injections, or treatments that reduce the immune system (inhaled or topical corticosteroid creams are allowed)
• People who have previously had a major organ transplant, including a kidney transplant
• People with a known allergy to rituximab, mouse-derived proteins, or any of its ingredients
• People with a known allergy to any of the medications given before the rituximab infusion
• People with contraindications to a specific pre-medication called Polaramine, including risk of a certain type of glaucoma or risk of urinary retention due to prostate or urinary tract conditions
• People who are expected to need a live vaccine during the study period, or who have an incomplete course of a live vaccine (live vaccines must have been given at least 30 days before joining)
• People who have not completed a full COVID-19 vaccination course (or do not have documented recovery from COVID-19) as approved in the country where they are being enrolled
• People who cannot have an MRI scan, including those with severe claustrophobia, a non-MRI-compatible pacemaker, metal objects in the eye, certain brain aneurysm clips, metallic devices in the back, or a known allergy to MRI contrast agents containing gadolinium
• People with known liver failure
• People with a history of a serious brain condition called progressive multifocal leukoencephalopathy
• People who have taken part in another clinical drug trial within the past 3 months
• People who are unable to follow the study procedures
• People who are under legal guardianship or curatorship

Important: Always verify eligibility with the trial site directly before applying.