A Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of RBD4059 in Participants with Stable Coronary Artery Disease

Launched by RIBOCURE PHARMACEUTICALS AB · Nov 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called RBD4059 to see if it is safe and effective for treating adults with stable coronary artery disease (CAD). Stable CAD means that patients have consistent heart-related symptoms, but they are not experiencing sudden or severe issues. The researchers will compare RBD4059 to a placebo, which is a dummy treatment that looks like the real drug but has no active ingredients. This will help them understand if RBD4059 can help improve heart health without causing significant side effects.

To participate in the trial, individuals need to be between 50 and 75 years old and willing to sign consent forms. They should have been diagnosed with stable CAD for over a year and must be on standard treatment with aspirin. Participants will visit the clinic 11 to 12 times over 11 to 14 months for check-ups and tests, depending on the group they are placed in. It’s important to note that some individuals may not be eligible, such as those with certain heart conditions, a history of significant bleeding, or those who have had major surgeries recently. Overall, the trial aims to provide valuable information about RBD4059 and its potential benefits for heart health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Willing and able to give written informed consent for participation in the trial.
• • Male or female (post-menopausal) participants ≥50-75 years.
• • Patients with stable CAD defined as chronic coronary syndromes according to ESCs guideline on chronic coronary syndromes including the category asymptomatic or symptomatic patients more than 1 year after initial diagnosis or revascularization.
• • Ongoing standard treatment with aspirin 75 mg for at least 3 months
• • Stable prescription drugs i.e., ongoing since at least 30 days prior to randomization, should continue during the trial.
• Main exclusion Criteria:
• • Presence of any significant arrythmia in opinion of the investigator
• • Any clinical suspicion on acute coronary syndrome or unstable angina at enrolment according to ESC criteria : (i) rest angina, i.e. pain of characteristic nature and location occurring at rest and for prolonged periods (more than 20 min); (ii) new-onset angina, i.e. recent (2 months) onset of moderate-to-severe angina (Canadian Cardiovascular Society grade II or III); or (iii) crescendo angina, i.e. previous angina, which progressively increases in severity and intensity, and at a lower threshold, over a short period of time.
• • Patients with other clinical scenarios qualifying in the ESC definition of chronic coronary syndromes: patients with suspected CAD and 'stable' anginal symptoms, and/or dyspnoea, with new onset of heart failure (HF) or left ventricular (LV) dysfunction and suspected CAD, with angina and suspected vasospastic or microvascular disease.
• • High bleeding risk defined as history of any significant bleeding (included but not limited to intracerebral haemorrhage and gastrointestinal), anaemia, liver failure, age more than 75 years or Clinical Frailty Score more than 5, or weight less than 60kg.
• • Major surgery during last 30 days or planned major surgery or intervention within trial period.
• • Capillary Hb less than 120 g/l for women and less than 130 g/L for men.
• • Elective PCIor CABG within the previous 12 months.
• • Previously confirmed ischemic stroke.
• • Ongoing indication for chronic anti-coagulation therapy (incl. but not limited to patients with: atrial fibrillation, venous thrombo-embolism, mechanical cardiac valves) with NOACs, warfarin or other similar anticoagulants.
• • Left ventricular ejection fraction (LVEF) less than 30% at enrolment.
• • New York Heart Association (NYHA) class III-IV heart failure at entry, hospitalization for exacerbation of chronic heart failure within the previous 12 months or other indices of unstable heart failure.
• • Creatinine clearance calculated by Cockcroft Gault equation less than 60ml/min\*m2 at the time of enrolment. Hemodynamically significant valvular disease or valvular disease likely to require surgery within 3 years.
• • Hemodynamically significant valvular disease or valvular disease likely to require surgery within 3 years.
• • Expected survival time is less than one year for non-cardiac related disorders.
• * History or presence of:
• • 1. Bleeding disorder(s) and/or at risk of bleeding, including relevant familial history.
• • 2. Thromboembolic diseases.