TAILOR BLEED
-
StatusAccepting Candidates
-
AgeN/A
-
SexesAll
-
Healthy Volunteers
Description
The purpose of this study is to evaluate the feasibility of switching patients from the standard dual antiplatelet therapy (DAPT) to single therapy of Ticagrelor or Prasugrel only or DAPT with Clopidogrel and Aspirin and to compare how platelets stick together with all of these treatment regimens.
Details
Protocol number | IRB202202835 |
Eligibility
Inclusion criteria:
Patients who presented with chronic coronary syndrome, underwent PCI and have been on maintenance treatment with DAPT, composed of low-dose aspirin (81mg od) and prasugrel (10 mg od) or ticagrelor (90 mg bid) for at least 30 days. Or patients that presented with an Acute coronary syndrome (ACS) event and underwent PCI and have been on maintenance treatment with DAPT, composed of low-dose aspirin (81mg od) and prasugrel (10mg od) or ticagrelor (90mg bid) for 3 months or greater. Age 18 – 100 years old Provide written informed consent
Exclusion criteria:
Prior history of stent thrombosis Acute Coronary Syndrome (ACS) within 3 months. 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) Renal failure requiring dialysis Patients with known bleeding diathesis or coagulation disorders Known severe hepatic impairment Hemodynamic instability Hypersensitivity to clopidogrel Pregnant and breastfeeding women [women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study]
Lead researcher
-
Dominick J Angiolillo, MD, PhDCardiologist, Interventional CardiologistLanguages: Italian, Spanish
Participate in a study
Here are some general steps to consider when participating in a research study:
-
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
-
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.
-
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.
-
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.