Ignite Creation Date:
2024-05-06 @ 9:01 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02889549
Status:
UNKNOWN
Last Update Posted:
2017-02-23
First Post:
2016-08-31
Brief Title:
Effects of Different Doses of Ticagrelor on Platelet Aggregation and Endothelial Function in Diabetic Patients With Stable Coronary Artery Disease
Sponsor:
First Affiliated Hospital of Harbin Medical University
Organization:
First Affiliated Hospital of Harbin Medical University
Study Overview
Official Title:
Effects of Different Doses of Ticagrelor and Standard-dose Clopidogrel on Platelet Aggregation and Endothelial Function in Diabetic Patients With Stable Coronary Artery Disease
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ticagrelor is an oral reversibly-binding direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes ACS Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients However few East Asian patients have been included in these trials to assess the use of these drugs In addition a growing body of data supported that East Asian might have different adverse event profiles thrombophilia and bleeding and therapeutic window compared with white subjects But it is still not clear whether a low dose of ticagrelor is superior to clopidogrel in diabetic patients with stable coronary disease
Recent studies found that antiplatelet drugs might have anti-inflammatory effects and protect endothelial function ACS patients treated by ticagrelor had a significantly higher increase in levels of circulating progenitor cells compared to those treated by clopidogrel suggesting a benefit on endothelial regeneration that may participate in the pleiotropic property of the drug This may prompt the regression of blood vessels and the endothelium stability But it is not very clear that the effect of low-dose ticagrelor on vascular endothelial function in diabetic patients with stable coronary artery disease
Therefore the investigators performed this randomized single-blind clinical trial to observe the effects of different doses of ticagrelor and standard-dose clopidogrel on platelet aggregation and endothelial function in diabetic patients with stable coronary artery disease
Recent studies found that antiplatelet drugs might have anti-inflammatory effects and protect endothelial function ACS patients treated by ticagrelor had a significantly higher increase in levels of circulating progenitor cells compared to those treated by clopidogrel suggesting a benefit on endothelial regeneration that may participate in the pleiotropic property of the drug This may prompt the regression of blood vessels and the endothelium stability But it is not very clear that the effect of low-dose ticagrelor on vascular endothelial function in diabetic patients with stable coronary artery disease
Therefore the investigators performed this randomized single-blind clinical trial to observe the effects of different doses of ticagrelor and standard-dose clopidogrel on platelet aggregation and endothelial function in diabetic patients with stable coronary artery disease
Detailed Description:
Ticagrelor is an oral reversibly-binding direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes ACS Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients However few East Asian patients have been included in these trials to assess the use of these drugs In addition a growing body of data supported that East Asian might have different adverse event profiles thrombophilia and bleeding and therapeutic window compared with white subjects In Korea and Japan it has been recently reported that low doses of ticagrelor might have a more potent inhibition of platelet aggregation than clopidogrel 75 mg once daily in healthy subjects and patients with stable coronary artery disease respectively But it is still not clear whether a low dose of ticagrelor is superior to clopidogrel in diabetic patients with stable coronary disease A recent study on pharmacokinetics and tolerability of ticagrelor has found that maximum plasma concentration and area under the plasma concentration-time curve of ticagrelor 90 mg twice daily and its active metabolite AR-C124910XX tended to be approximately 40 higher in healthy Chinese volunteers compared with Caucasian subjects This data also suggested that a low dose of ticagrelor might be more appropriate for Chinese patients with coronary heart disease In view of a large diurnal variation with a single daily dose a lower dose twice daily may be a better choice for Chinese patients
Recent studies found that antiplatelet drugs might have anti-inflammatory effects and protect endothelial function ACS patients treated by ticagrelor had a significantly higher increase in levels of circulating progenitor cells compared to those treated by clopidogrel suggesting a benefit on endothelial regeneration that may participate in the pleiotropic property of the drug This may prompt the regression of blood vessels and the endothelium stability But it is not very clear that the effect of low-dose ticagrelor on vascular endothelial function in diabetic patients with stable coronary artery disease
Therefore the investigators performed this randomized single-blind clinical trial to observe the effects of different doses of ticagrelor and standard-dose clopidogrel on platelet aggregation and endothelial function in diabetic patients with stable coronary artery disease
Recent studies found that antiplatelet drugs might have anti-inflammatory effects and protect endothelial function ACS patients treated by ticagrelor had a significantly higher increase in levels of circulating progenitor cells compared to those treated by clopidogrel suggesting a benefit on endothelial regeneration that may participate in the pleiotropic property of the drug This may prompt the regression of blood vessels and the endothelium stability But it is not very clear that the effect of low-dose ticagrelor on vascular endothelial function in diabetic patients with stable coronary artery disease
Therefore the investigators performed this randomized single-blind clinical trial to observe the effects of different doses of ticagrelor and standard-dose clopidogrel on platelet aggregation and endothelial function in diabetic patients with stable coronary artery disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None