Safety and Efficacy of Low-dose Ticagrelor in Chinese Patients With Stable Coronary Artery Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | July 2015 |
| End Date: | November 2015 |
| Contact: | Meijiao He, MM |
| Email: | hemeijiao99@sina.com |
| Phone: | 86-451 -85555673 |
Safety and Efficacy of Low-dose Ticagrelor in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Trial
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.
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.
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 (22.5 mg twice daily) in
comparison to clopidogrel (75mg once daily) in Chinese patients with stable coronary artery
disease.
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 (22.5 mg twice daily) in
comparison to clopidogrel (75mg once daily) in Chinese patients with stable coronary artery
disease.
Inclusion Criteria:
- Stable Coronary Artery Disease
1. stable angina
2. low-risk unstable angina
3. variant angina
4. patients with asymptomatic with appropriate therapy（including percutaneous
coronary intervention）.
Exclusion Criteria:
1. ACS
2. planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP)
receptor antagonists, or anticoagulant therapy during the study period
3. platelet count <100g/L
4. creatinine clearance rate < 30ml/min
5. diagnosed as respiratory or circulatory instability (cardiac shock, severe congestive
heart failure NYHA II-IV or left ventricular ejection fraction < 40%)
6. a history of bleeding tendency
7. aspirin, ticagrelor or clopidogrel allergies
8. diabetes.
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