Clinical study for cardiovascular disease now enrolling
You may be eligible to take part in this global clinical study
People who take part may receive*:
- study-related care at no cost
- study medication at no cost.
There is no obligation, so see if you may qualify now.
About the EASi-PROTKT™ studyWhat is the EASi-PROTKT™ study?
If you have high blood pressure (HBP), type 2 diabetes (T2D), and cardiovascular disease (CVD), the EASi-PROTKT™ clinical study could be a good fit for you. While lifestyle changes and current medications offer some protection, many people with HBP, T2D, and CVD still experience worsening of their condition over time. This increases the risk of further cardiovascular complications and kidney damage.
This clinical study (also known as a clinical trial) aims to find out how safe it is to combine an investigational medication with an approved medication called empagliflozin for people with HBP, T2D, and CVD. The study also wants to see whether this combination could help people with HBP, T2D, and CVD reduce their risk of developing serious heart health events, including heart failure, and support kidney function.
About 11,800 adults from around the world will take part in this study. Study participation will last between 2.5–4.25 years.
What is cardiovascular disease?
Cardiovascular disease is a general term for conditions that affect the heart and/or blood vessels. There are many types of cardiovascular disease, including:
- coronary heart disease
- peripheral artery disease
- cerebrovascular disease, such as strokes and transient ischemic attacks (also known as mini strokes).
About the study medications
High levels of the hormone aldosterone can contribute to serious heart health events, including heart failure, as well as kidney damage. The investigational medication in this study is designed to potentially protect the heart by reducing the extra aldosterone that the body makes. Empagliflozin is an approved medication for T2D, heart disease, and chronic kidney disease. It helps protect the heart by removing extra sugar and salt from the blood.
We hope that by using the investigational medication and empagliflozin together, we may be able to reduce the risk of serious heart health events in the future.
This dual approach – combining the investigational medication with empagliflozin – is already being studied in people with chronic kidney disease, where it has shown promising results.
Some participants will be given a placebo (a tablet that looks like the investigational medication but contains no active medicine) and empagliflozin daily. Many clinical studies (like this one) use a placebo to help researchers get a clearer picture of how the investigational medication works.
You will be given the study medications (investigational medication + empagliflozin or placebo + empagliflozin) as oral tablets.
What to expect
Your health and well-being will be closely monitored throughout the study with scheduled clinic visits and telephone calls.
Health assessments will include:
The EASi-PROTKT™ study is split into 3 periods: screening period, treatment period, and follow-up period.
1
Screening period
Up to 3 weeks
We will carry out some health checks to make sure you and the study are a good fit.
2
Treatment period
Between 2.5–4.25 years
You will be randomly assigned to 1 of following groups.
- Group 1: You will be given the investigational medication and empagliflozin daily.
- Group 2: You will be given the placebo and empagliflozin daily.
You will have an equal chance of joining either group.
3
Follow-up period
You will have 1 follow-up visit about 1 week after your last dose of the study medication. We will carry out some health checks during this visit.**
**If you discontinue treatment earlier, this visit will not apply to you.
What is a clinical study?
A clinical study, also called a clinical trial or research study, is a carefully designed scientific evaluation of an investigational medication. Clinical studies are conducted by doctors and researchers. A clinical study helps to answer important questions about an investigational medication, such as:
- How safe is the investigational medication?
- Does it work?
What is a potential new medication?
An investigational medication, also sometimes called an investigational drug or a study medication, has been tested in a laboratory. Based on those results, it has been approved by health regulatory authorities for testing in people. An investigational medication also may be a medication that is approved for the treatment of one disease or condition but is still under investigation in other diseases or conditions. An investigational medication can only be used in clinical research studies.
All investigational medications must be tested in clinical studies before they can be approved by health regulatory authorities to be prescribed to patients. We need people to take part in clinical research studies so that new medications can be developed.
After reading all the information on this website, I still have questions about trying an investigational medication that may not work. Can you give me more information?
There are always risks and benefits of participating in a clinical research study. There is always a chance that the investigational medication could cause side effects or will not work. However, you should know that there are strict rules in place to monitor the safety of people taking part in a study. Before joining any clinical study, it is important to consider the risks and understand them.
The study team will explain all the risks and benefits at the first study visit. Throughout the study, a team of doctors and nurses will monitor the health of the people taking part. They will be there to answer any questions you may have.
What happens after a decision is made to take part in the study?
If you would like to know whether you might be able to take part in the study, please fill out the form. You will be told immediately if the study is a good match. If you pre-qualify, we will connect you to a clinical research study center in your area. We will also help schedule the first study appointment at the study center. Please note: During the screening process, the study doctor or study team will check additional criteria before someone can join the study.
Is there a cost to take part?
The study-required investigational medication or placebo will be provided at no cost. The person taking part in the study will also receive study-related care from a team of experienced doctors and nurses throughout the study at no cost.
Will participant confidentiality be protected?
All personal information will remain confidential, and data will only be collected and used as necessary to support an individual’s match to and participation in a study. Participants’ names will not be included in any data reported. For more information, including how and why we process personal data, please read our Privacy Policy.
Are clinical studies safe?
Clinical studies must undergo rigorous reviews and follow strict rules. These rules help to ensure that the rights, safety, and well-being of participants are at the forefront of any study.
Participating in a clinical study comes with risks as well as benefits. Before joining a study, potential participants must make sure they understand the benefits, such as getting access to study-related medical care and maybe helping others in the future. They must also understand the risks, such as unknown side effects. Potential study participants can take as much time as they need to decide whether to take part and get as much information as they can. Before joining a study, the potential study participant will be asked to sign an informed consent form, which will include a full explanation of the study, including its potential risks. If the potential study participant is not capable of giving informed consent, a legally authorized representative may provide informed consent on their behalf. In this situation, the potential study participant would provide informed assent.
What else should someone who is thinking about taking part in a clinical study consider?
It is a personal decision to take part. Participation in the study is voluntary. Please also consider:
- If a decision is made to participate, you can withdraw at any time during the study.
- The study team will explain the possible benefits and risks of the study during the informed consent process.
- A person does not have to join any study if they don’t want to.
- A team of doctors and nurses will carefully monitor the health of people taking part during the study.
- The investigational medication or placebo will be provided at no cost.
- Taking part in the study may help other people with CVD in the future.
People taking part in the study will need to follow all the instructions from the study doctor and nurses.
See If You Pre-Qualify
