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

Phase 4

Recruiting

• Conditions: Acute Coronary Syndrome Patients With Diabetes After PCI
• Interventions: Drug: Ticagrelor; Drug: Aspirin

• Registration Number: NCT04307511
• Lead Sponsor: Shanghai Tong Ren Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-08
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-13
• Study Start: 2020-04-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-22
• Primary Completion: 2024-04-30
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose DAPT therapy	Ticagrelor	treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard DAPT(ticagrelor 90mg plus aspirin 100 mg )treatment
low dose DAPT therapy	Aspirin	treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard DAPT(ticagrelor 90mg plus aspirin 100 mg )treatment
standard dose DAPT therapy	Ticagrelor	treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group
standard dose DAPT therapy	Aspirin	treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group

Primary Outcome Measures

Name	Time	Method
changes of PRI detected by VASP	changes of PRI from baseline (1 months after index PCI) to 2 months after index PCI	platelet reactivity index (PRI) detected by VASP (Vasodilator Stimulated Phosphoprotein) Phosphoprotein)
changes of Maximum Amplitude (MA) detected by TEG	changes of MA from baseline (1 months after index PCI) to 2 months after index PCI	Maximum Amplitude (MA) detected by TEG(Thromboelastography)

Trial Locations

Locations (1)

shanghai Tongren hospital; 🇨🇳 Shanghai, China