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STRENGTH Trial

Help Us Explore a Potential Way to Protect Your Heart

 

This web page contains information that may help you decide whether you would like to take part in the STRENGTH Trial.

 

 

 

What is the STRENGTH Trial?

The STRENGTH Trial is looking at an investigational medication for people who have high levels of triglycerides (a type of fat in the blood that can raise your risk of heart disease) and other risk factors for heart disease. The investigational medication is a concentrate of omega-3 free fatty acids, developed from fish oils.

 

In previous large clinical research studies that for lasted six to 12 weeks, the investigational medication was found to help lower triglyceride levels. The STRENGTH Trial will look at whether this investigational medication can lower triglyceride levels and prevent serious events such as heart attacks and strokes when taken for longer periods of time. This study will involve approximately 13,000 people and will last for about three to five years.

 

If you take part in this study, you will have an equal chance of receiving the investigational medication or an alternative, which contains corn oil. Which medication you receive will be decided by chance (like flipping a coin) and neither you nor the study team will know which study medication you are taking. Both study medications will be provided as capsules to be taken orally (by mouth) once a day throughout the study.

 

In addition to taking the study medication, you will be asked to follow a recommended low-cholesterol diet program called the Therapeutic Lifestyle Changes (TLC) diet or a similar diet recommended by your physician.

 

 

What will happen during the STRENGTH Trial?

If you take part in the STRENGTH Trial, you will receive the study medication for up to 5 years.

 

The study is divided into two periods called screening and treatment.

 

Screening period (up to 20 weeks)

• To check whether the study is right for you

• Includes up to four visits to the study center

 

Treatment period (up to 5 years)

 

You will receive capsules to take once a day containing either:

• a concentrate of omega-3 free fatty acids (the investigational medication), or

• corn oil

 

A visit to the study center or a follow-up telephone call will take place approximately once every 6 months during this period

 

What will happen at the study visits?

If you decide to take part in the STRENGTH Trial, your general wellbeing and the health of your heart will be monitored by a team of doctors and nurses. Study assessments at one or more visits will include:

• physical examinations

• a measurement of height, weight, and waist circumference

• blood pressure and heart rate measurements

• an electrocardiogram (ECG; to check the health of your heart)

• blood and urine tests.

 

Who can take part in this research study?

You may be able to take part in the STRENGTH Trial if you:

• are 18 years of age or older

• take a statin medication but still have high triglyceride levels

• have at least one risk factor for heart disease, such as:

– a history of heart problems or stroke

– type 1 or 2 diabetes

– high blood pressure or taking a blood pressure medication

– being a regular smoker.

A study doctor will review your previous medications and carry out some additional assessments at one or more screening visits to ensure that this study is right for you.

 

Want to know more?

To learn more about this study and discuss your eligibility to join, please complete and submit the form at this link, or contact the study team using the details below. We look forward to hearing from you.

 

Baylor Scott & White Research Institute

Fort Worth Clinical Trial Office

817.922.2587 

 

 

 



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