The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel
1 other identifier
interventional
279
1 country
27
Brief Summary
This is a multi-center, randomized, double-blind, triple-dummy, parallel-controled, dose-exploration phase II trial. Patients with coronary atherosclerotic heart disease and planned percutaneous coronary intervention （PCI） will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups: Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days; Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days; Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days; Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days. The primary purpose of this trial is to evaluate the efficacy, safety of vicagrel antiplatelet therapy and explore dose in patients with coronary atherosclerotic heart disease during and after PCI compared with clopidogrel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 coronary-artery-disease
Started Aug 2018
Shorter than P25 for phase_2 coronary-artery-disease
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedStudy Start
First participant enrolled
August 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2019
CompletedSeptember 23, 2019
July 1, 2018
10 months
July 9, 2018
September 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Inhibition of platelet aggregation
Inhibition of platelet aggregation will be assessed by Verifynow System
28 days after treatment
Study Arms (4)
Experimental group 1
EXPERIMENTALExperimental group 1: Vicagrel 20mg loading followed by 5mg/day for 28 days
Experimental group 2
EXPERIMENTALExperimental group 2: Vicagrel 24mg loading followed by 6mg/day for 28 days
Experimental group 3
EXPERIMENTALExperimental group 3: Vicagrel 30mg loading followed by 7.5mg/day for 28 days
Control group
ACTIVE COMPARATORControl group: Clopidogrel 300mg loading followed by 75mg/day for 28 days
Interventions
Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days
Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days
Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days
Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days
Eligibility Criteria
You may qualify if:
- Male and female aged 18-75.
- 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.
You may not qualify if:
- 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);
- 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;
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
First Affiliated Hospital Bengbu Medical College
Bengbu, Anhui, 233004, China
Beijing Anzhen Hospital, Capital Medical Universily
Beijing, Beijing Municipality, 100029, China
Guangdong General Hospital
Guangzhou, Guangdong, 510030, China
First Affiliated Hospital of Zhongshan University
Guangzhou, Guangdong, 510080, China
First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050100, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022, China
Changsha Central Hospital
Changsha, Hunan, 410004, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Zhongda Hospital of Southeast University
Nanjing, Jiangsu, 210009, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
First Hospital of Jilin University
Changchun, Jilin, 130021, China
Second Hospital of Jilin University
Changchun, Jinin, 130041, China
the General Hospital of Shenyang Military Region of The Chinese People's Liberation Army（The General Hospital of Shenyang Military）
Shenyang, Liaoning, 110015, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, 110015, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110134, China
Qinghai Provincial People's Hospital
Xining, Qinghai, 810007, China
Yuncheng Central Hospital
Yuncheng, Shanxi, 044000, China
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310020, China
China-Japan Friendship Hospital
Beijing, 100029, China
Peking Union Medical College Hospital
Beijing, 100032, China
Tianjin People's Hospital
Tianjin, 300121, China
Tianjin Medical University General Hospital
Tianjing, 300052, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2018
First Posted
July 26, 2018
Study Start
August 30, 2018
Primary Completion
June 11, 2019
Study Completion
July 28, 2019
Last Updated
September 23, 2019
Record last verified: 2018-07