Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II
This study aims to find the most effective low-dose aspirin treatment for people with type 2 diabetes. Some people with type 2 diabetes don't respond well to standard aspirin doses, which is important because aspirin helps prevent blood clots. In this study, we first give participants a common low-dose aspirin for 7 days. If the aspirin isn't working as well as it should to thin their blood, they will then try three different aspirin treatments: a higher dose of enteric-coated aspirin once a day, a lower dose of enteric-coated aspirin twice a day, or a very low dose of chewable aspirin twice a day. The main goal is to see which of these options works best to thin the blood and to prepare for a larger study in the future.
At a glance
What is this study about?
This study is looking into how different types and doses of aspirin work in people who have type 2 diabetes. Aspirin is often prescribed to help prevent blood clots in people at risk, and this includes many individuals with type 2 diabetes. However, we know that for some people, the standard low-dose aspirin doesn't seem to work as effectively to thin their blood. This is a common issue and doctors need to know the best way to help aspirin do its job.
The main purpose of this study is to discover the best way to give aspirin to these individuals. We want to find out which form and dose of aspirin works best to improve its effects on blood clotting. This information will help doctors in the future make better decisions about aspirin treatment for people with type 2 diabetes, especially those who don't respond well to current standard doses.
Ultimately, the results of this study will help us understand more about how aspirin works and pave the way for bigger studies that could lead to improved care and reduced risks for people living with type 2 diabetes.
Key takeaways
- Aims to find the best low-dose aspirin treatment for type 2 diabetes.
- Specifically for people where standard aspirin doesn't thin blood effectively.
- Involves trying different aspirin types and doses over several weeks.
- Regular blood tests check how well aspirin is working.
- Results will help improve future aspirin treatment guidelines.
- Participation involves taking daily aspirin and attending clinic visits.
Who may be eligible?
To join this study, you need to be at least 18 years old and have type 2 diabetes. You shouldn't have taken aspirin regularly in the last 3 months, or any aspirin at all in the last 2 weeks. You also need to be willing and able to come to all the study visits.
There are also some reasons why you might not be able to join. For example, if you already take aspirin for a known heart condition, or if you have a history of allergies to aspirin. We also can't include people with serious liver problems, a high risk of stomach bleeding, or certain blood disorders. If you are pregnant or breastfeeding, or planning major surgery, you also wouldn't be able to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have type 2 diabetes?
- Have you avoided taking aspirin for at least the last 2 weeks (and regularly for the last 3 months)?
- Are you able to come to all scheduled study appointments?
- Do you have any serious liver problems or a high risk of stomach bleeding?
- Are you pregnant or breastfeeding, or planning major surgery soon?
What does participation involve?
If you decide to take part, the study will involve several visits over a few weeks. At your first visit, we'll take a blood sample to check how your blood clots normally. If you meet the criteria, you'll then be asked to take a standard low-dose aspirin tablet once a day for 7 days at home.
After 7 days, you'll have another visit where we'll take more blood samples, both before and a couple of hours after you take your aspirin for that day. If we find that the aspirin isn't working well enough to thin your blood, you'll then try three different aspirin treatments, one after the other. Each of these will be taken for 7 days, with visits to check your blood after each period. In total, the study could last several weeks, with regular blood tests to see how the different aspirin doses are affecting your blood.
Potential risks and benefits
Locations (1)
- Montreal Heart InstituteVerified postcodeMontreal, Canada· Recruiting
Common questions
What is 'platelet aggregation'?
Platelet aggregation is when tiny blood cells called platelets stick together to form clots. Aspirin helps stop them from sticking too much, which can prevent harmful blood clots.
Why is this study important for people with type 2 diabetes?
People with type 2 diabetes often have a higher risk of blood clots. This study helps us find the best way to use aspirin to prevent these clots, especially when standard doses don't work well.
What does 'enteric-coated' aspirin mean?
Enteric-coated means the aspirin tablet has a special coating that helps it pass through your stomach without dissolving, aiming to reduce stomach upset.
Will I know which aspirin dose I'm taking?
Yes, this study is 'open-label,' which means you and the study team will know which aspirin dose and type you are taking at each stage.
Will I have to pay for the aspirin or the study visits?
No, all study medications and visits are provided at no cost to you as part of your participation.
How to find out more
Guillaume Marquis Gravel, MD, MSc
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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