SWAP 7
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StatusAccepting Candidates
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Age18 Years - 99 Years
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SexesAll
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Healthy Volunteers
Description
You are being asked to participate in this study because you have a stent in your heart artery for at least 90 days and you are currently taking blood-thinning medications as part of your standard of care. In particular, you are taking two blood-thinning medications, which include baby aspirin plus either Prasugrel (Effient) or Ticagrelor (Brilinta). These blood-thinning medications prevent your blood cells, called platelets, from sticking together, which helps to prevent clots and heart attacks. While these medications are effective at preventing your stent from clotting and heart attacks, they also increase the risk of bleeding. To reduce the risk of bleeding while still protecting your heart, doctors sometimes use a strategy called “de-escalation” of blood thinning medication. One of the methods of de-escalation involves stopping aspirin after the first 90 days after your stent is placed and continuing to take your other blood thinner (Prasugrel or Ticagrelor). Research shows that de-escalation can lower the risk of bleeding without increasing the risk of stent clotting or heart attacks. However, there are no studies which compare the blood thinning effects of Prasugrel and Ticagrelor after stopping aspirin. Therefore, the purpose of this study is to see how Prasugrel or Ticagrelor without aspirin will work in your body.
Details
| Protocol number | IRB202401578 |
Eligibility
Inclusion criteria:
- Patients on DAPT with aspirin plus prasugrel 10 mg or ticagrelor 90 mg bid as per standard of care at least 90 days after PCI.
- Age between 18 and 75 years old
- Able to provide written informed consent
Exclusion criteria:
- Prior history of stent thrombosis
- PCI within 90 days.
- History of stroke/TIA
- Age > 75 years old
- Weight < 60 kg
- History of intracranial hemorrhage
- On treatment with any oral anticoagulant or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis)
- Patients with known coagulation disorders
- Known severe hepatic impairment
- Hypersensitivity to prasugrel or ticagrelor
- Pregnant and breastfeeding persons [persons of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study]. If the potential subject is a person of childbearing potential, a pregnancy test will be done. If the subject is pregnant, participation in this study will end.
Lead researcher
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
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Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.