Anterior STEMI revascularised by PPCI MedDRA version: 19.0 Level: LLT Classification code 10066641 Term: Acute myocardial infarction, of anterior wall System Organ Class: 100000004849
Conditions
Sponsors
Papworth Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old 2. Acute anterior STEMI and successful primary percutaneous coronary intervention (PCI) with stent inplantation in the culpirt lesion during the first 24hrs after onset of symptoms 3. Provision of written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. Previous history of STEMI 2. Cardiogenic shock (systolic blood pressure 500msecs using Bazett's formula 4. Hematologic abnormalities (hemoglobin 2xULN) 7. Active or recurrent hepatitis (type B) 8. Known HIV infection 9. Current or previous tuberculosis (CXR) 10. Current infections 11. Presence or history in the previous five years of an ongoing cancer, except in situe cancer of the cervix or basal cell carcinoma 12. Any oral or intravenous immunosuppressive treatment (other than concomitant 100mg methylprednisolone), disease modifying drugs or other immue modulatory monoclonal antibodies 13. Allergy to rituximab or one of its excipients 14. Expected need for vaccination with a live attenuated vaccine during the study including incomplete vaccination courses 15. Known or suspected preganacy at screening or lactating women 16. Women of childbearing age unless confirmed by direct questioning that they are reproductively sterile or post menopausal 17. Participation in other clinical trials 18. Inability to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the lowest dose of rituximab with the highest biological efficacy (B cell depletion) and the best safety profile (lowest incidence of undesirable effects) in patients with acute anterior myocardial infraction treated by PPCI.;Secondary Objective: To determine the infarct size by serial cardiac biomarker release.;Primary end point(s): To assess the safety of rituximab in ST-elevation myocardial infarction (STEMI) patients by monitoring their response to the drug in a controlled environment and on extended follow up.;Timepoint(s) of evaluation of this end point: Primary outcome measures will be assessed at days 1-6, day 14, day 30 and 6 months post infusion via: • Review of Adverse Events and Serious Adverse Events • Clinically significant changes in biochemical and haematological markers (serum creatinine, eGFR, liver function tests, blood glucose, full blood count and differential) • Clinically significant ECG changes (arrhythmias, ischaemic changes, QTc) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the effect of rituximab on circulating B cells immediately after administration and on extended follow up.;Timepoint(s) of evaluation of this end point: Secondary endopoints i.e. kinetics and extent of reduction of B lymphocyte number in blood post infusion of Rituximab will be assessed at 30 mins, 6 hours, days 6, 14 and 6 months post infusion. | — |
Countries
United Kingdom
Contacts
Public ContactSarah Fielding
Papworth Hospital NHS Foundation Trust
Outcome results
None listed