Not recruiting

Study of RBD4059 and acetylsalicylic acid in patients with stable coronary artery disease: evaluation of safety and drug behavior in the body

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with Stable Coronary Artery Disease, a condition where the arteries that supply blood to the heart have become narrowed or blocked. The study will test a new medication called RBD4059, which is given as an injection under the skin. Participants in the study will continue taking their regular dose of acetylsalicylic acid (75 mg daily), commonly known as aspirin, which they have been using for their heart condition.

The main purpose of this research is to evaluate how safe RBD4059 is when given as multiple doses to patients with stable heart disease who are already taking low-dose aspirin. During the study, some participants will receive the actual medication while others will receive a placebo through injections under the skin. The treatment period will last for 12 months.

The study will involve regular check-ups to monitor participants' health, including blood tests, physical examinations, and heart measurements using ECG (a test that records the heart's electrical activity). The researchers will also measure how the body processes the medication and how it affects certain blood components related to clotting. Neither the participants nor their doctors will know who is receiving the actual medication or the placebo during the study.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation and medication verification
Your eligibility for the study will be confirmed based on age (50-75 years) and diagnosis of stable coronary artery disease
Your current use of aspirin 75 mg will be verified (must be taking it for at least 3 months)
Your current medications will be reviewed (must be stable for at least 30 days)
Step 2
Treatment assignment
You will be randomly assigned to receive either RBD4059 injections or a placebo (inactive substance)
The placebo contains vitamin B2 for coloring purposes
You will continue taking your daily aspirin 75 mg tablet throughout the study
Step 3
Treatment administration
You will receive subcutaneous injections (under the skin) of either RBD4059 or placebo
The treatment period will continue through multiple doses
Your regular medications, including aspirin 75 mg, should be maintained during this period
Step 4
Monitoring and assessments
Regular health checks will include blood tests, vital signs, physical examinations, and heart recordings (ECG)
Blood samples will be taken to measure drug levels and assess its effects
Your blood clotting will be monitored through specific tests
You will be checked for any immune system responses to the study medication
Step 5
Study completion
The study is expected to run until December 31, 2025
Final assessments will be conducted to evaluate your health status
Your participation will end after completing all required visits and assessments

Who can join the trial?

8 criteria

Must be able and willing to provide written consent to participate in the study
Age must be between 50 and 75 years old
check
Can be either:
- Male, or
- Female who has gone through menopause
- Must have stable coronary artery disease (a condition where the heart's blood vessels are narrowed) for more than 1 year after initial diagnosis or treatment
- Must be taking aspirin 75 mg as regular treatment for at least 3 months
- Must be on stable medications that have not changed in the last 30 days before starting the study, and must continue these medications during the study
- Can be either experiencing symptoms or be symptom-free, as long as the condition has been stable for more than 1 year

Who cannot join the trial?

16 criteria

Age below 18 years or above 65 years
Patients with unstable coronary artery disease (heart condition that is not stable or well-controlled)
History of severe allergic reactions to medications
Current use of blood thinners other than low-dose aspirin
Pregnancy or breastfeeding
Participation in other clinical trials within the past 30 days
Significant kidney or liver problems
Uncontrolled high blood pressure
Recent heart attack or stroke (within the last 6 months)
Active bleeding disorders
Major surgery planned during the study period
History of blood clotting disorders
Severe heart failure
Any condition that could interfere with the study medication absorption
Unable to provide informed consent
History of non-compliance with medical treatments

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Ribocure Pharmaceuticals AB
Molndal, Sweden

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

RBD4059
is an investigational medication being tested in patients with stable coronary artery disease. It is given as multiple injections under the skin (subcutaneously) to patients who are already taking low-dose aspirin. The medication is being studied to understand how safe it is and how it works in the body.
Aspirin
is a commonly used medication that helps prevent blood clots. In this trial, participants take low-dose aspirin as part of their regular treatment for coronary artery disease. It works by making blood platelets less sticky, which reduces the risk of blood clots forming in the arteries of the heart.

What is already known about the treatment

RBD4059 - An investigational medication administered subcutaneously (under the skin) that is currently being studied in Phase IIa clinical trials for patients with stable Coronary Artery Disease (CAD). The drug is being evaluated in combination with low-dose aspirin therapy, suggesting potential cardiovascular benefits. While the exact mechanism of action is still under investigation through clinical trials, this experimental treatment is being tested for its safety profile, how it moves through the body (pharmacokinetics), and how it affects the body (pharmacodynamics) in patients with stable heart disease. The medication is currently not approved for general medical use as it is still in the research phase.

Investigated diseases

Coronary Artery Disease (CAD) - A condition where the major blood vessels that supply the heart become damaged or diseased. It develops when fatty deposits, cholesterol, and other substances build up in the walls of coronary arteries, forming plaques. These deposits cause the arteries to narrow over time, reducing blood flow to the heart muscle. The disease typically develops over decades, and symptoms may not be noticeable until significant narrowing of the arteries has occurred. When the condition stabilizes with consistent symptoms and does not show rapid progression, it is referred to as stable CAD.