SWAP 9
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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
People are considered for participation in this trial when. they are taking two blood-thinning medications, which include baby aspirin plus either Prasugrel (Effient) or Ticagrelor (Brilinta). These blood-thinning medications prevent blood cells, called platelets, from sticking together, which helps to prevent clots and heart attacks. While these medications are effective at preventing stents from clotting, they also increase the risk of bleeding. To reduce the risk of bleeding while still protecting the heart, doctors sometimes use a strategy called “de-escalation” of blood thinning medication. This involves either continuing to take the stronger blood thinner (Prasugrel or Ticagrelor) for the first month after the stent is placed and stopping aspirin or switching to a less potent blood thinner called Clopidogrel (Plavix®) while maintaining aspirin. Research shows that deescalation can lower the risk of bleeding without increasing the risk of stent clotting. The approach towards de-escalation of blood thinning medications can be done in two ways: guided by laboratory tests or unguided. Both methods are commonly used and recommended by cardiology guidelines. However, no studies have considered how genetics and other clinical factors might guide the switching of medications. This study aims to use genetics and other clinical factors by means of a scoring system called ABCD-GENE (Age, Body Mass Index, Chronic Kidney Disease, Diabetes Mellitus, and Genotyping) to better guide de-escalation of blood-thinning medications for each individual.
Details
| Protocol number | IRB202400929 |
Eligibility
Inclusion criteria:
- Patients who have undergone PCI and are on maintenance treatment with DAPT, composed of low-dose aspirin (81mg qd) with either prasugrel (10 mg qd) or ticagrelor (90 mg bid). In particular, patients who underwent PCI in the setting of an acute coronary syndrome will be eligible for randomization after ≥90 days post-PCI, while patients who underwent PCI in the setting of a chronic coronary syndrome ≥30 days post-PCI.
- Age >18 years old
- Provide written informed consent.
Exclusion criteria:
- Prior history of stent thrombosis
- PCI within 30 days
- On treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban) or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis)
- Hemodynamic instability
- Hypersensitivity to Aspirin, Clopidogrel[SL1] , Ticagrelor or Prasugrel
- Known hematologic malignancies or thrombocytopenia (platelet count <80x106/mL)
- Known hemoglobinopathies or anemia (hemoglobin <9 g/dL)
- Pregnant and breastfeeding women [women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study]
Probably would include any known hematologic malignancy, thrombocytopenias, etc.
ASA/hypersensitivity to other anti platelet therapy discussed at FB mtg 9/18/24
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.