- Dose-finding Study of YMI024 to Assess Efficacy, Safety, and Tolerability in Adults With Stable Coronary Artery Disease and Elevated hsCRP — Recruiting • Phase II • Cardiology / Cardiovascular • NCT07830719.
- Sponsor: Novartis Pharmaceuticals.
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The purpose of this Phase 2b study is to investigate the efficacy in reducing systemic inflammation, safety, tolerability, and dose response of five doses of YMI024, as compared to placebo in adult participants with stable coronary artery disease (CAD) and residual inflammatory risk defined by elevated high-sensitivity C-reactive protein (hsCRP) (≥2 mg/L)
- : 1. Signed informed consent must be obtained prior to any study specific procedures, and participant able to understand and comply with study requirements. 2. Male and female participants aged between 18-80 years (inclusive) at Screening. 3. Documented stable CAD as evidenced by presence of at least one of the following criteria: 1. Documented history of spontaneous (Type 1) myocardial infarction (MI) of presumed atherosclerotic origin that occurred at least 30 days before the start of Screening. If a Pre-screening visit is conducted, the MI must have occurred at least 30 days before that visit. Diagnosis of the qualifying MI should be based on medical records and Investigator's judgment. 2. Prior coronary revascularization (i.e. percutaneous coronary intervention (PCI) at least 30 days prior, or coronary artery bypass grafting (CABG), at least 6 months prior to Screening). * Any prior PCI must have occurred at least 30 days prior to the Screening Visit (or if conducted, prior to the Pre screening visit). * Any prior CABG must have occurred at least 6 months (i.e. 26 weeks) prior to the Screening (or if conducted, prior to the Pre-screening) Visit. 3. Angiographic or CT-imaging (e.g., Multi Detector Computed Tomography/ Computed Tomography Angiography…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.