coronary atherosclerotic heart disease
Conditions
Interventions
Experimental group 1:Vicagrel 5mg
Experimental group 2:Vicagrel 6mg
Experimental group 3:Vicagrel 7.5mg
Control group:Clopidogrel 75mg
Sponsors
the General Hospital of Shenyang Military Region of The Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female aged 18-75 years; 2) Weight = 50kg; 3) Patients with coronary atherosclerotic heart disease diagnosed clinically and planned percutaneous coronary intervention; 4) Patients with ability and willingness to sign informed consent and adherence to trial protocol.
Exclusion criteria
Exclusion criteria: 1) Hemorrhagic symptoms (such as hematemesis, melena, severe or recurrent epistaxis, hemoptysis, marked hematuria, gastrointestinal bleeding, or intracranial hemorrhage), or suspected vascular malformations (such as aneurysms), or abnormal bleeding history (such as abnormal hemorrhage attributed to tooth extraction), himself or his immediate family with coagulation or bleeding disorders (such as hemophilia); 2) Acute myocardial infarction within 7 days (acute ST-segment elevation myocardial infarction or acute non-ST-segment elevation myocardial infarction); 3) Patients with suspected aortic dissection; 4) Predicted left main stenosis >50%; 5) Predicted total number of stents > 3 or number of lesions (>50% per lesion stenosis) > 2 or number of stents in the same vascular lesion > 2; 6) Patients with negative coronary CTA (coronary CTA depending on investigator); 7) Patients with severe disease and life expectancy 1.3 times the upper limit of normal or international normalized ratio (INR)> 2.0 20) Platelet count (PLT) 600×10^9/L; 21) Hemoglobin < 10g/dL; 22) Patients who cannot tolerate dual antiplatelet therapy for 28 days; 23) Female of reproductive age with positive blood pregnancy test; 24) Female with gestational intention or in lactation; 25) Other unsuitable conditions considered by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inhibition of platelet aggregation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of MACE;Incidence of bleeding events;Incidence of AE;Pharmacokinetic indicators;Genotyping of CYP2C19; | — |
Countries
China
Contacts
Public ContactYongqiang Liu
Jiangsu vcare pharmaceutical technology co., LTD
Outcome results
None listed