NCT02214654

A Pilot Study To Examine The Effects Of Ticagrelor To Protect Against Type 2 Diabetes-Induced Vascular Damage

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 144 (estimated)
• Sponsor: Tianjin Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare clopidogrel with ticagrelor which one has stronger anti-inflammation effect to protect against type 2 diabetes-induced vascular damage.

Detailed description

i- Verify the study inclusion and exclusion criteria at visit 1. ii- Inform patients (verbally and in writing) and their caregivers (when considered necessary and with the patient's consent) of the characteristics of the study and confirm their agreement to participate by signing the informed consent document. iii- Assist with patient assessment, record the information in the case report form. Based on the data we get from the case report form, assign the patient to the experimental or control group by stratified randomization. ⅳ- At visit 2 to obtain blood sample from peripheral vessel and analyze the density of CECs,sCD40L and hs-CRP by flow cytometry (FCM), ELISA and particle-enhanced turbidimetric immunoassay. ⅴ- All patients are given aspirin 100mg/qd orally and the experimental group given ticagrelor 90mg/bid while the control group clopidogrel 75mg/qd for 30 days. ⅵ- At visit 3 repeating step ⅳ and making comparison on numbers of CECs and CD40L between the two groups, and finish a statistic analysis.

Conditions

• Type 2 Diabetes Mellitus；
• Stable Coronary Disease

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-03-01
• Completion: 2015-06-01
• First posted: 2014-08-12
• Last updated: 2014-08-12

Locations

2 sites across 1 country: China