Safety and Efficacy of Low-dose Ticagrelor in Chinese Patients With Stable Coronary Artery Disease
Status:
Unknown status
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
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 (22.5 mg
twice daily) in comparison to clopidogrel (75mg once daily) in Chinese patients with stable
coronary artery disease.
Phase:
Phase 4
Details
Lead Sponsor:
First Affiliated Hospital of Harbin Medical University