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

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What is this study about?

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.

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)

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

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

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

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 Study?

Must be able and willing to provide written consent to participate in the study
Age must be between 50 and 75 years old
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 Study?

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

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Rmbkltzl Piqfirvgtvqnrbv Ao	Molndal	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	01.08.2024

Trial locations

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.

Investigated diseases:

Coronary artery disease

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.

Trial ID:

2023-510370-14-00

Protocol code:

RC03T001

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?