Clinical Trials Logo
  1. Home
  2. Coronary Heart Disease
  3. NCT06097663

A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 and MAS825 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP)

Coronary Heart Disease Clinical Trial

Official title:
A Randomized, Placebo-controlled, Parallel-group, Investigator- and Participant-blinded Phase 2a Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 and MAS825 for Inflammatory Marker Reduction in an Adult Population With Coronary Heart Disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP)

Clinical Trial Summary

This Phase 2a clinical trial will evaluate the effectiveness, safety, and tolerability of increasing dose strengths of an oral daily medication, DFV890, administered for 12 weeks, or a single s.c. dose of MAS825, to reduce key markers of inflammation related to CVD risk, such as IL-6 and IL-18, in approximately 28 people with known coronary heart disease and TET2 or DNMT3A CHIP (VAF ≥2%).

Clinical Trial Description

This is a multi-center, randomized, placebo-controlled, participant- and investigator-blinded study. The study consists of a screening period up to 30 days; a treatment period of approximately 12 weeks with an end of treatment (EOT) visit on Day 85, which is one day after the last dose of DFV890 or placebo; a follow-up period of approximately 1 week; and a standard safety follow-up call approximately 30 days following the last dose. The overall study duration is approximately 21 weeks. Participants will be randomized to one of five treatment sequences. Based on the treatment sequence assignments, participants will start on either a combination of MAS825 and placebo, DFV890 and placebo, or placebo and placebo on Day 1, and then, within each DFV890 treatment sequence, participants will receive up-titrating doses of DFV890 or placebo at the corresponding study visits. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06097663
Study type Interventional
Source Novartis
Contact Novartis Pharmaceuticals
Phone 1-888-669-6682
Email novartis.email@novartis.com
Status Recruiting
Phase Phase 2
Start date February 15, 2024
Completion date February 24, 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Completed NCT05088291 - Application of a New X-ray Protective Device in Coronary Interventional Therapy
Completed NCT03076801 - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease? N/A
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Not yet recruiting NCT04995159 - Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System N/A
Recruiting NCT02967718 - Innovation Research of Differentiation and Treatment Methods Based on CHD Phlegm and Blood Stasis Syndrome N/A
Completed NCT02888652 - Study on the Registration of Coronary Heart Disease Patients Undergoing PCI
Terminated NCT02045134 - Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery N/A
Completed NCT02163044 - The Hellenic Postprandial Lipemia Study (HPLS)
Active, not recruiting NCT02244853 - Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease N/A
Completed NCT01826552 - Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent Phase 4
Completed NCT02753829 - Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease N/A
Completed NCT02440893 - Understanding the Effect of Metformin on Corus CAD (or ASGES)
Terminated NCT01906957 - Cognition and Exercise Training N/A
Completed NCT01920009 - Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines N/A
Recruiting NCT01689688 - Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography N/A
Completed NCT01779401 - Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients N/A
Recruiting NCT01462799 - COR-PRIM: Problem-based Learning (PBL) After Coronary Heart Disease (CHD) - Long-term Evaluation in Primary Care of Self-care N/A
Recruiting NCT01456364 - Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing Phase 4
Completed NCT01486030 - Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD (or ASGES) Diagnostic Test