Rituximab in Patients With Acute ST-elevation Myocardial Infarction Study (RITA-MI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03072199|
Recruitment Status : Active, not recruiting
First Posted : March 7, 2017
Last Update Posted : March 25, 2019
RITA-MI aims to develop of a novel therapeutic concept to target the immune response in patients with acute myocardial infarction (MI) by depleting B-cells with a single injection of Rituximab which is approved for clinical use in cancer, autoimmune disease and inflammatory conditions. The goal is to re-purpose the drug, and translate the discovery into benefit for patients at high risk of cardiovascular events. Rituximab is expected to limit infarction size and improve the healing process, as complementary to other therapeutic strategies.
The applicants intend to perform a clinical study in patients with acute myocardial infarction (MI). The objective is to find the optimal dose (lowest dose with highest biological efficacy and best safety profile) for peripheral blood B cell depletion during the first 6 days after injection, and selective molecular signatures associated with improved heart function through analysis of peripheral blood samples.
The study rationale is to decrease the inflammatory reaction upon tissue necrosis following heart muscle ischemia.
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Heart Disease Myocardial Infarction Inflammation||Drug: RiTUXimab Injection||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Phase 1/2 unblinded interventional dose escalation study|
|Masking:||None (Open Label)|
|Official Title:||Rituximab in Patients With Acute ST-elevation Myocardial Infarction Study|
|Actual Study Start Date :||June 1, 2017|
|Actual Primary Completion Date :||March 1, 2019|
|Estimated Study Completion Date :||September 1, 2019|
Drug: RiTUXimab Injection
Single dose of Rituximab given intravenously within 48hours of myocardial infarction
- Safety - Review of Adverse Events and Serious Adverse Events; [ Time Frame: 6month ]Adverse and serious adverse events will be reviewed by daily history taking and clinical examination of patients whilst they are an inpatient. Subsequently patients will be followed up on discharge daily until day 6 with telephone follow up. On days 6, 14 and 6month patients will be assess again in an outpatient setting where adverse events will be documented. There is additional follow telephone follow up at day 30. After each group of 6 patients are recruited and infused with rituximab, an independent Data and Safety Monitoring Board will review the clinical and biological data and their side effect profile, including adverse events.
- Safety - Clinically significant changes in biochemical and haematological markers [ Time Frame: 6month ]Biochemistry and haematology bloods will be taken daily after drug administration whilst an inpatient. Upon discharge bloods will be taken on days 6, 14 and 6month for further assessment. Any new abnormalities will be flagged. After each group of 6 patients are recruited and infused with rituximab, an independent Data and Safety Monitoring Board will review the clinical and biological data and their side effect profile, including adverse events.
- Safety - Clinically significant ECG changes [ Time Frame: 6month ]Arrhythmia will be assess as patients will have continued cardiac monitoring whilst an inpatient. ECGs will be performed daily whilst an inpatient and also during outpatient attendance. QTc will be assessed using the Bazett formula. After each group of 6 patients are recruited and infused with rituximab, an independent Data and Safety Monitoring Board will review the clinical and biological data and their side effect profile, including adverse events.
- B cells [ Time Frame: Days 0, 6, 14 and 6months ]Circulating B cells count before, immediately after administration (30 mins and 6 hours), and extended follow up (6 days, 14 days and 6months)
- Cardiac biomarkers - Circulating inflammatory (hsCRP and IL6) and cardiovascular (BNP and Troponin) biomarkers. [ Time Frame: Days 0, 2 and 6 months ]These will be measure before the infusion and compared to after infusion on days 2, 6 and 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072199
|Papworth Hospital NHS Trust|
|Cambridge, Cambridgeshire, United Kingdom, CB23 3RE|