A sTudy of Low Dose vs Standard Dose of tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Diabetes Mellitus Patients

Launched by SHANGHAI TONG REN HOSPITAL · Mar 12, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how effective a lower dose of a medication called ticagrelor is compared to the standard dose in patients with diabetes who have had a procedure called percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). The researchers want to find out if the lower dose (60 mg) works as well as the standard dose (90 mg) in preventing blood clots. The study will involve 40 participants, who will be randomly divided into two groups. One group will receive the standard dose along with aspirin for 12 months, while the other group will start with the standard dose for one month and then switch to the lower dose for the next 11 months.

To be eligible for this trial, participants must be between 18 and 89 years old, have diabetes, and have recently undergone successful PCI. They need to understand the study and provide consent to participate. Throughout the trial, participants will have their platelet function tested at one and two months after the procedure, and their health will be monitored for 12 months to track any clinical events. This study may help determine if a lower dose of ticagrelor can be safely used, which could potentially benefit patients by reducing medication costs and side effects.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Subject must be at least 18 years of age and less than 90 years old
• • 2. Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome with diabetes mellitus.
• • 3. Subject understand the study requirements and the treatment procedures and
• • 4. provided informed consent before the procedure
• Exclusion Criteria:
• • 1. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
• • 2. Active bleeding
• • 3. Known hypersensitivity or contraindication to study medications
• • 4. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
• • 5. Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment).
• • 6. Subjects with Cerebral hemorrhage history
• • 7. Subjects with stroke history in half a year
• • 8. subjects with active malignant tumor
• • 9. subjects with whom oral anticoagulants are needed
• • 10. Other conditions which the investigators think not applicable to the study.