Rituximab in Patients With ST-elevation Myocardial Infarction
ConditionST Elevated Myocardial Infarction
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
The main objective is to compare the effect of a single injection of two doses of rituximab versus placebo on 6 months left ventricular systolic function, using CMR, in patients who have had an acute anterior STEMI. Following the sponsor's decision to stop enrolment in the 200 mg arm, the primary objective of the study is to evaluate the efficacy of a single 1000 mg dose of rituximab versus placebo.
The primary endpoint is the left ventricular ejection fraction (LVEF) by CMR at 6 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years with no upper limit (women must be either postmenopausal defined as being amenorrhoeic for greater than 2 years with an appropriate clinical profile, e.g. age appropriate (>55 years old), history of vasomotor symptoms) or having documented hysterectomy and/or bilateral oophorectomy) ;
- Clinical evidence at presentation of anterior ST-elevation myocardial infarction (STEMI) defined as symptoms suggestive of acute myocardial ischemia, an electrocardiogram showing ST-segment elevation ≥2 mm in ≥2 contiguous leads in V1 to V4 or a large inferior MI with evidence of low-ejection fraction (LVEF<45%);
Complete occlusion (i.e. TIMI flow 0-1) of proximal or mid left anterior descending (LAD) coronary artery on urgent angiography interpreted as the infarct-related artery (IRA);
Onset of worse symptoms within 48 hours before primary PCI;
Disqualifiers
History of previous MI without documented preserved left ventricular ejection fraction (LVEF >50%) prior to the current admission will be an exclusion criterion;
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Active arm 1000 mg
DrugActive arm 1000 mg: 1 bag containing 1000 mg of rituximab\* in 500 ml of NaCl 0.9% \* Mabthera® and all registered biosimilars are likely to be used in this trial
Placebo arm
DrugPlacebo arm: 1 bag of 500 ml of NaCl 0.9%
Treatment groups
372 Participants
are divided into 2 treatment groupsGroup A: Active arm 1000 mgExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Left ventricular ejection fraction (LVEF) by CMR at 6 months.
To compare the effect of a single injection of two doses of rituximab versus placebo on 6 months left ventricular systolic function, using CMR, in patients who have had an acute anterior STEMI.
Time frame
6 monthsSecondary outcomes
1
Infarct size by CMR
To compare the effects of rituximab versus placebo on infarct size by CMR at day 5 (+/-2) and at 6 months.
Time frame
At day 5 (+/-2) and at 6 months2
Oedema extension by CMR
To compare the effects of rituximab versus placebo on oedema extension by CMR at day 5 (+/-2) .
Time frame
At day 5 (+/-2)3
T2 relaxation time at ischemic region by CMR
To compare the effects of rituximab versus placebo on T2 relaxation time at ischemic region by CMR (using T2 mapping) at day 5 (+/-2).
Time frame
At day 5 (+/-2)4
Microvascular obstruction by CMR
To compare the effects of rituximab versus placebo on microvascular obstruction by CMR (hypointense areas within LGE) at day 5 (+2/-) .
Time frame
At day 5 (+/-2)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Source ClinicalTrials.gov