The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel

Coronary Artery Disease Clinical Trial

Official title:

The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel in Patients With Coronary Atherosclerotic Heart Disease and Planned Percutaneous Coronary Intervention: a Multi-center, Randomized, Double-blind, Triple-dummy , Parallel-controlled, Dose-exploration Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599284
• Other study ID #: VCP1-?-01
• Status: Completed
• Phase: Phase 2
• Start date: August 30, 2018
• Est. completion date: July 28, 2019

Study information

• Verified date: July 2018
• Source: Jiangsu vcare pharmaceutical technology co., LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: July 28, 2019
• Est. primary completion date: June 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 ?b/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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Percutaneous Coronary Intervention
• Platelet Aggregation Inhibitors

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical Universily	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing
China	First Affiliated Hospital Bengbu Medical College	Bengbu	Anhui
China	First Hospital of Jilin University	Changchun	Jilin
China	Second Hospital of Jilin University	Changchun	Jinin
China	Changsha Central Hospital	Changsha	Hunan
China	Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	First Affiliated Hospital of Zhongshan University	Guangzhou	Guangdong
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	Affiliated Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Zhongda Hospital of Southeast University	Nanjing	Jiangsu
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
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	First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tianjin People's Hospital	Tianjin
China	Tianjin Medical University General Hospital	Tianjing
China	Wuhan Asia Heart Hospital	Wuhan	Hubei
China	Qinghai Provincial People's Hospital	Xining	Qinghai
China	Yuncheng Central Hospital	Yuncheng	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu vcare pharmaceutical technology co., LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inhibition of platelet aggregation	Inhibition of platelet aggregation will be assessed by Verifynow System	28 days after treatment