Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
3043 participants
INTERVENTIONAL
2017-12-13
2019-02-13
Brief Summary
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Detailed Description
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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. Recent study found that ticagrelor 90mg twice a day orally could significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular events. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in Chinese patients with stable CAD. But large-scale clinical trials are still needed to confirm the effects of low-dose ticagrelor on platelet function in Chinese patients with coronary heart disease.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ticagrelor 45mg bidpo.
To observe the efficacy and safety of ticagrelor 45mg bidpo. in patients with coronary artery disease.
Ticagrelor
ticagrelor 45 mg twice daily for 5 consecutive days at least.
ticagrelor 90mg qdpo.
To observe the efficacy and safety of ticagrelor 90mg qdpo. in patients with coronary artery disease.
ticagrelor
ticagrelor 90 mg once daily for 5 consecutive days at least.
ticagrelor 90mg bidpo.
To observe the efficacy and safety of ticagrelor 90mg bidpo. in patients with coronary artery disease.
ticagrelor
ticagrelor 90 mg twice daily for 5 consecutive days at least.
clopidogrel 75mg qdpo.
To observe the efficacy and safety of clopidogrel 75mg qdpo. in patients with coronary artery disease.
clopidogrel
clopidogrel 75 mg once daily for 5 consecutive days at least.
Interventions
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Ticagrelor
ticagrelor 45 mg twice daily for 5 consecutive days at least.
ticagrelor
ticagrelor 90 mg once daily for 5 consecutive days at least.
ticagrelor
ticagrelor 90 mg twice daily for 5 consecutive days at least.
clopidogrel
clopidogrel 75 mg once daily for 5 consecutive days at least.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* anti-platelet therapy with clopidogrel or ticagrelor for less than 5 days;
* previous or current treatment with any other potentially confounding drugs.
18 Years
ALL
No
Sponsors
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Beijing Anzhen Hospital
OTHER
The First Affiliated Hospital of Dalian Medical University
OTHER
The Central Hospital of Jia Mu Si City
UNKNOWN
First Affiliated Hospital of Kunming Medical University
OTHER
RenJi Hospital
OTHER
Tianjin Medical University General Hospital
OTHER
Weifang People's Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Shengjing Hospital
OTHER
Shaanxi Provincial People's Hospital
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
Responsible Party
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Principal Investigators
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Yue Li, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University
Locations
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Thromboela-Stogram
Beijing, , China
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ACS-2
Identifier Type: -
Identifier Source: org_study_id
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