The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel
NCT ID: NCT03599284
Last Updated: 2019-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
279 participants
INTERVENTIONAL
2018-08-30
2019-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental group 1
Experimental group 1: Vicagrel 20mg loading followed by 5mg/day for 28 days
Vicagrel 5mg
Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days
Experimental group 2
Experimental group 2: Vicagrel 24mg loading followed by 6mg/day for 28 days
Vicagrel 6mg
Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days
Experimental group 3
Experimental group 3: Vicagrel 30mg loading followed by 7.5mg/day for 28 days
Vicagrel 7.5mg
Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days
Control group
Control group: Clopidogrel 300mg loading followed by 75mg/day for 28 days
Clopidogrel 75mg
Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days
Interventions
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Vicagrel 5mg
Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days
Vicagrel 6mg
Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days
Vicagrel 7.5mg
Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days
Clopidogrel 75mg
Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days
Eligibility Criteria
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Inclusion Criteria
* Weight ≥ 50 kg
* Patients with coronary atherosclerotic heart disease diagnosed clinically and planned percutaneous coronary intervention
* Patients with ability and willingness to sign informed consent and adherence to trial protocol.
Exclusion Criteria
* Non-ST-segment elevation acute coronary syndrome (\<2h emergency PCI), or ST-segment elevation myocardial infarction within 7 days;
* Patients with suspected aortic dissection;
* Patients with negative coronary Computed Tomography angiography（CTA）(coronary CTA depending on investigator);
* Patients with severe disease and life expectancy \<1 year;
* Patients with acute peptic ulcer;
* History of hemorrhagic stroke or history of ischemic stroke within 6 months before screening and a definite diagnosis of structural abnormalities in the central nervous system;
* Patients with uncontrolled high blood pressure (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg) after drug treatment during screening;
* One of the following conditions: cardiogenic shock, chronic congestive heart with failure New York Heart Association (NYHA) grade ≥ III grade or left ventricular ejection fraction determined by echocardiography \< 35%, hypotension (systolic pressure \< 90 mmHg and or diastolic pressure \< 60 mmHg), severe arrhythmias (including high-degree atrioventricular block, sick sinus syndrome, persistent ventricular tachycardia), severe pulmonary insufficiency, pulmonary embolism, and hepatic insufficiency (ALT or AST caused by non-cardiac diseases exceeding the upper limit of normal by more than 3 times), severe renal insufficiency (eGFR \< 30 ml/min), cirrhosis;
* Patients Received P2Y12 receptor antagonist and Ⅱb/IIIa receptor inhibitor, oral anticoagulant (warfarin, rivaroxaban, dabigatran, etc.) within 14 days before screening;
* Prolonged cardiopulmonary resuscitation (more than 10 minutes) or severe trauma within 2 weeks before screening;
* Patients plan to undergo another surgery within 1 month after participating in this trial，or plan to undergo PCI procedure performed several times during the test (except for the end of the safety follow-up);
* History of severe allergies, non-allergic drug reactions or allergies to 2 or more drugs (including contrast agents), or known allergies to the similar drugs (clopidogrel, ticagrelor) as the study drug or contraindication of aspirin;
* Patients with mental disorders or alcohol dependence;
* Patients being receiving any experimental medicine or experimental medical devices;
* Prothrombin time (PT)\> 1.3 times the upper limit of normal or international normalized ratio (INR)\> 2.0;
* Platelet count (PLT) \< 100×10\^9/L or \> 600×10\^9/L;
* Hemoglobin \< 10g/dL;
* Patients who cannot tolerate dual antiplatelet therapy for 28 days;
* Female of reproductive age with positive blood pregnancy test;
* Female with gestational intention or in lactation;
* Other unsuitable conditions considered by investigators.
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu vcare pharmaceutical technology co., LTD
INDUSTRY
Responsible Party
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Locations
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First Affiliated Hospital Bengbu Medical College
Bengbu, Anhui, China
Beijing Anzhen Hospital, Capital Medical Universily
Beijing, Beijing Municipality, China
Guangdong General Hospital
Guangzhou, Guangdong, China
First Affiliated Hospital of Zhongshan University
Guangzhou, Guangdong, China
First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Changsha Central Hospital
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Zhongda Hospital of Southeast University
Nanjing, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
First Hospital of Jilin University
Changchun, Jilin, China
Second Hospital of Jilin University
Changchun, Jinin, China
the General Hospital of Shenyang Military Region of The Chinese People's Liberation Army（The General Hospital of Shenyang Military）
Shenyang, Liaoning, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Qinghai Provincial People's Hospital
Xining, Qinghai, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
China-Japan Friendship Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Tianjin People's Hospital
Tianjin, , China
Tianjin Medical University General Hospital
Tianjing, , China
Countries
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Other Identifiers
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VCP1-Ⅱ-01
Identifier Type: -
Identifier Source: org_study_id
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