NCT04307511

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Tong Ren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Coronary Syndrome Patients With Diabetes After PCI

Interventions

Type	Name	Description
DRUG	Ticagrelor	60mg ticagrelor based DAPT vs 90mg ticagrelor based DAPT vs 90mg ticagrelor monotherapy
DRUG	Aspirin	Aspirin

Timeline

• Start date: 2020-04-20
• Primary completion: 2024-04-30
• Completion: 2024-05-31
• First posted: 2020-03-13
• Last updated: 2024-04-22

Locations

1 site across 1 country: China