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Clinical Trial Details

Title
A Randomized Comparison of Platelet Inhibition Using a Low Maintenance Dose Ticagrelor Regimen Versus Standard Dose Clopidogrel in Diabetes Mellitus Patients Without Prior Major Cardiovascular Events Undergoing Elective Percutaneous Coronary Intervention: The OPTIMUS (Optimizing Antiplatelet Therapy in Diabetes Mellitus)-6 Study
Study Description

The primary purpose of this study is to measure how sticky your platelets are at different time points after receiving ticagrelor or clopidogrel. This is the part of the research study that is under investigation. In particular, platelets are a type of blood cells. When you have a cut or break in your skin, platelets have an important job of traveling to the area and forming a clot or scab to stop the bleeding. The stickier your platelets are, the greater your chances of having heart attacks, strokes, or clots in your stents.

If you meet the requirements to be in the study, you will need to see your study doctor again to begin your treatment. This is known as the Randomization/First Dose visit and will occur at the time of coronary angiography. You will be randomly assigned to take either ticagrelor or clopidogrel, along with aspirin. If you are randomized to receive clopidogrel, you will receive a 600 mg loading dose followed by 75 mg daily dose and your daily 81 mg aspirin. If you are randomized to receive ticagrelor, you will receive a 180 mg loading dose followed by a 60 mg twice a day dose and your 81 mg aspirin. You will take the first dose of study drug in the catheterization laboratory after the diagnostic angiography procedure is performed. After the diagnostic angiography procedure is over and it has been determined that a PCI is necessary as your standard of care, you will take either 180 mg of ticagrelor or 600 mg clopidogrel. If you are assigned to ticagrelor, you will start taking 60 mg of ticagrelor twice daily starting 12 hours after the first dose. If you are assigned to clopidogrel, you will start taking 75 mg of clopidogrel once daily starting 24 hours after the first dose. You will be taking the assigned study medication for up to 33 days. You will need to provide blood samples on the first two days. This may happen more than once per day, depending on the study visit day. You will have blood samples taken up to 8 hours after the first dose administration. You will be asked to come to our clinical site after 30±3 days from your PCI in the morning, before your morning dose of clopidogrel or ticagrelor, to re-assess how sticky your platelets are. After this blood draw, the study will be over and you will resume your standard of care therapy as instructed by your treating physician.

Investigators

Principal Investigator
Dominick J. Angiolillo, M.D., Ph.D., FACC
Medicine

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