NCT03072199 (RITA-MI) is a Phase 1, PHASE2 clinical trial of RiTUXimab Injection in Ischemic Heart Disease, sponsored by Papworth Hospital NHS Foundation Trust.

Who is sponsoring NCT03072199?

NCT03072199 is sponsored by Papworth Hospital NHS Foundation Trust.

What drugs are being tested in NCT03072199?

Interventions in NCT03072199: RiTUXimab Injection.

What condition does NCT03072199 study?

NCT03072199 studies Ischemic Heart Disease, Myocardial Infarction, Inflammation.

Is NCT03072199 still recruiting?

NCT03072199 is currently completed. Last updated 14 September 2021.

Last reviewed 2021-09-14 · How we verify

NCT03072199: RITA-MI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Rituximab in Patients With Acute ST-elevation Myocardial Infarction Study

Completed Phase 1, PHASE2 Last updated 14 September 2021

What this trial tests

Phase 1, PHASE2 trial testing RiTUXimab Injection in Ischemic Heart Disease in 24 participants. Completed in 1 May 2021.

Timeline

1 June 2017

Primary endpoint
1 March 2019

1 May 2021

Quick facts

Lead sponsor	Papworth Hospital NHS Foundation Trust
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	1 June 2017
Primary completion	1 March 2019
Estimated completion	1 May 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

RiTUXimab Injection — full drug profile →

Conditions studied

Ischemic Heart Disease — all drugs for Ischemic Heart Disease →
Myocardial Infarction — all drugs for Myocardial Infarction →
Inflammation — all drugs for Inflammation →

Sponsor

Papworth Hospital NHS Foundation Trust

Who can join

Adults 18 to 75, any sex, with Ischemic Heart Disease or Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Myeloid cell contributions to cardiovascular health and disease.
Nahrendorf M. · · 2018 · cited 217× · PMID 29867229 · DOI 10.1038/s41591-018-0064-0
Inflammatory and Molecular Pathways in Heart Failure-Ischemia, HFpEF and Transthyretin Cardiac Amyloidosis.
Michels da Silva D, Langer H, Graf T. · · 2019 · cited 56× · PMID 31083399 · DOI 10.3390/ijms20092322
Rituximab in patients with acute ST-elevation myocardial infarction: an experimental medicine safety study.
Zhao TX, Aetesam-Ur-Rahman M, Sage AP, Victor S, et al · · 2022 · cited 50× · PMID 33783498 · DOI 10.1093/cvr/cvab113
Immune and Inflammatory Networks in Myocardial Infarction: Current Research and Its Potential Implications for the Clinic.
Anzai A, Ko S, Fukuda K. · · 2022 · cited 44× · PMID 35563605 · DOI 10.3390/ijms23095214
Considering Cause and Effect of Immune Cell Aging on Cardiac Repair after Myocardial Infarction.
Tobin SW, Alibhai FJ, Weisel RD, Li RK. · · 2020 · cited 22× · PMID 32823583 · DOI 10.3390/cells9081894
Imaging as a surrogate marker of drug efficacy in cardiovascular disease.
Tarkin JM, Dweck MR, Rudd JHF. · · 2019 · cited 10× · PMID 30381320 · DOI 10.1136/heartjnl-2017-311213
Immunomodulatory Treatment Strategies Targeting B Cells for Heart Failure.
Zhang X, Sun Y, Wang N, Zhang Y, et al · · 2022 · cited 6× · PMID 35350762 · DOI 10.3389/fphar.2022.854592
At the Intersection of Cardiology and Oncology: TGFβ as a Clinically Translatable Therapy for TNBC Treatment and as a Major Regulator of Post-Chemotherapy Cardiomyopathy.
Sulaiman A, Chambers J, Chilumula SC, Vinod V, et al · · 2022 · cited 4× · PMID 35326728 · DOI 10.3390/cancers14061577

Verify or expand the search:

Other trials of RiTUXimab Injection

Trials testing the same drug.

NCT06341205 — Personalized Rituximab Treatment Based on Artificial Intelligence in Membranous Nephropathy (iRITUX) · Phase 3 · recruiting
NCT05898308 — Comparison of a Personalized Maintenance Therapy With the Standard Treatment in Pemphigus · Phase 4 · recruiting
NCT05990985 — The Efficacy and Safety of the RCMOP Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high · NA · not yet recruiting

Other recruiting trials for Ischemic Heart Disease

Currently open trials in the same condition.

NCT07399002 — LONG NAGOMI™ PMCF STUDY · recruiting
NCT07083557 — Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiome · recruiting
NCT06712862 — A Clinical Study of Evaluating Myocardial Viability in Ischemic Heart Disease with Integrated 18F-FDG PET/MR · recruiting
NCT07009418 — Smart Angioplasty Research Team-Coronary CT Angiography Versus Standard Care as Follow-up Strategies in High-Risk Patien · NA · recruiting
NCT06891456 — Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia · NA · recruiting

Other Papworth Hospital NHS Foundation Trust trials

Trials by the same sponsor.

NCT07289100 — Novel Sensors and Artificial Intelligence for Detection of Acute Pulmonary Exacerbations in Cystic Fibrosis and Bronchie · recruiting
NCT06433960 — Radial Artery Assessment in Surgical Coronary Revascularisation · completed
NCT05775263 — Validation of UK Protocols to Exclude Brain Blood Flow During Normothermic Regional Perfusion (NRP) · unknown
NCT06421792 — PrOtamIne doSing clOt imagiNg (POISON) Study · not yet recruiting
NCT06072872 — Portable Continuous Positive Airways Pressure (CPAP) in Excessive Central Airway Collapse (ECAC) Study · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03072199 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Papworth Hospital NHS Foundation Trust
Last refreshed: 14 September 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03072199.

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