Clinical trial NCT04307511: A sTudy of Low Dose vs Standard Dose of tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Diabetes Mellitus Patients
Official title: A Randomized Controlled sTudy of Low Dose vs Standard Dose of tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acute Coronary Syndrome Patients With Diabetes After PCI
Lead sponsor: Shanghai Tong Ren Hospital
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigates try to confirm the hypothesis that low dose ticagrelor(60mg) had similar anti-platelets function compared with the standard dose ticagrelor in acute coronary syndrome patients with diabetes. Totally 40 ACS patients with diabetes will be divided into 2 groups randomly after PCI for one month. Group 1 will be treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group; Group2 will be treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard DAPT treatment. The platelets function will be tested in VASP and TEG methods at 1 and 2 months after PCI as the primary endpoints.The clinical events will be observed 12 months after PCI.


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.

Primary outcomes:
measure: changes of PRI detected by VASP
timeFrame: changes of PRI from baseline (1 months after index PCI) to 2 months after index PCI
measure: changes of Maximum Amplitude (MA) detected by TEG
timeFrame: changes of MA from baseline (1 months after index PCI) to 2 months after index PCI
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: shanghai Tongren hospital
Study officials:
References: