Ignite Creation Date:
2024-05-06 @ 7:21 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02514642
Status:
UNKNOWN
Last Update Posted:
2015-09-30
First Post:
2015-07-21
Brief Title:
Safety and Efficacy of Low-dose Ticagrelor in Chinese 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:
Safety and Efficacy of Low-dose Ticagrelor in Chinese Patients With Stable Coronary Artery Disease a Randomized Single-blind Crossover Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2015-07
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 DAPT have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for patients who have an ACS with or without ST-segment elevation However few East Asian patients or those of East Asian descent have been included in these trials to assess the use of these drugs In Korea and Japan it has been reported that low doses of ticagrelor might have a more potent inhibition of platelet aggregation IPA 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 a large population of Chinese ACS patients 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 ACS patients 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 Therefore the investigators performed this randomized single-blind crossover clinical trial to observe the efficacy and safety of low-dose ticagrelor 225 mg twice daily in comparison to clopidogrel 75mg once daily in Chinese 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 DAPT have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for patients who have an ACS with or without ST-segment elevation However few East Asian patients or those of East Asian descent 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 Furthermore East Asian paradox phenomenon has been also described that East Asian patients have a higher prevalence of platelet reactivity during DAPT but an ischaemic event rate following percutaneous coronary intervention PCI or ACS is similar or even lower than white patients In Korea and Japan it has been reported that low doses of ticagrelor might have a more potent inhibition of platelet aggregation IPA 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 a large population of Chinese ACS patients 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 ACS patients 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 Therefore the investigators performed this randomized single-blind crossover clinical trial to observe the efficacy and safety of low-dose ticagrelor 225 mg twice daily in comparison to clopidogrel 75mg once daily in Chinese 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