Johese Clinical Research specialises in high cholesterol studies.
What is cholesterol?
Cholesterol is a type of fat (lipid) in your blood. If you have too much cholesterol, it starts to build up in your arteries. This is called hardening of the arteries, or artheriosclerosis. The buildup can narrow the arteries and make it harder for blood to flow through them. The buildup can also lead to dangerous blood clots and inflammations that can cause heart attacts and strokes.
What is a clinical research study?
• Clinical research studies help to determine whether potential new medications (known as “investigational medications”) are safe and how well they work.
• In a clinical research study, a group of people agree to take the investigational medication whilst being looked after by study doctors, nurses and other staff.
• Clinical research studies provide the best information for health-related decision-making, new medications and new treatments.
What is the CLEAR Outcomes Study?
The CLEAR Outcomes Study will include more than 12,000 people worldwide who have cardiovascular disease (also known as heart disease), or who are at high risk for cardiovascular disease, and who cannot tolerate taking cholesterol-lowering medications called statin medications. The main purpose of the CLEAR Outcomes Study is to see if an investigational medication reduces the risk of major cardiovascular (heart and blood vessel-related) events in participants
with, or at high risk for, cardiovascular disease. The study will also look at how the investigational medication may affect the level of cholesterol and how safe it is.
Can I take part in the study?
You may be able to take part in the CLEAR Outcomes Study if you:
• are at least 18 years of age, or the age considered an adult in your country, whichever is older, up to 85 years of age
• have, or are at high risk for, cardiovascular disease
• cannot tolerate taking statin medications (have tried at least one statin medication, but you had problems taking them because of side effects).
If you have tried only one statin medication, you may be able to take part if you are unwilling to try another statin medication or if a physician advised you not to try another statin medication.
At the first study visit, the study team will check whether the study is right for you.
What will happen at the study visits?
There will be a number of health checks and tests. They may include:
• questions about your health and medical history
• physical examination (a check of your overall health, including your height and weight)
• a check of your vital signs (blood pressure and pulse)
• blood and urine tests
• pregnancy tests (if you are a woman able to have children)
• electrocardiogram (ECG; to check your heart rhythm).
Not all of these tests will be done at every visit.
What else do I need to consider?
Taking part in the CLEAR Outcomes Study is your choice.
The study team will explain the risks and benefits of taking part in the study.
Who should I contact for more information?
If you are interested in learning more about the CLEAR Outcomes Study, please contact the study team of JOHESE using the links below.