The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors
• Intervention / Treatment: Drug: Vicagrel 5mg; Drug: Vicagrel 6mg; Drug: Vicagrel 7.5mg; Drug: Clopidogrel 75mg

• Study Type: Interventional
• Enrollment (Actual): 279
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100029
    • China-Japan Friendship Hospital
  • Beijing, China, 100032
    • Peking Union Medical College Hospital
  • Tianjin, China, 300121
    • Tianjin People's Hospital
  • Tianjing, China, 300052
    • Tianjin Medical University General Hospital
  • Anhui
    • Bengbu, Anhui, China, 233004
      • First Affiliated Hospital Bengbu Medical College
  • Beijing
    • Beijing, Beijing, China, 100029
      • Beijing Anzhen Hospital, Capital Medical Universily
  • Guangdong
    • Guangzhou, Guangdong, China, 510030
      • Guangdong General Hospital
    • Guangzhou, Guangdong, China, 510080
      • First Affiliated Hospital of Zhongshan University
  • Hebei
    • Shijiazhuang, Hebei, China, 050100
      • First Hospital of Hebei Medical University
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Asia Heart Hospital
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410004
      • Changsha Central Hospital
    • Changsha, Hunan, China, 410011
      • Second Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410013
      • Third Xiangya Hospital of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Affiliated Drum Tower Hospital of Nanjing University Medical School
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital of Southeast University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Provincial People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • First Hospital of Jilin University
  • Jinin
    • Changchun, Jinin, China, 130041
      • Second Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110015
      • the General Hospital of Shenyang Military Region of The Chinese People's Liberation Army（The General Hospital of Shenyang Military）
    • Shenyang, Liaoning, China, 110015
      • The People's Hospital of Liaoning Province
    • Shenyang, Liaoning, China, 110134
      • Shengjing Hospital of China Medical University
  • Qinghai
    • Xining, Qinghai, China, 810007
      • Qinghai Provincial People's Hospital
  • Shanxi
    • Yuncheng, Shanxi, China, 044000
      • Yuncheng Central Hospital
  • Sichuan
    • Luzhou, Sichuan, China, 646000
      • Affiliated Hospital of Southwest Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliated Hospital of Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310020
      • Sir Run Run Shaw Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group 1; Experimental group 1: Vicagrel 20mg loading followed by 5mg/day for 28 days	Drug: Vicagrel 5mg; Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days
Experimental: Experimental group 2; Experimental group 2: Vicagrel 24mg loading followed by 6mg/day for 28 days	Drug: Vicagrel 6mg; Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days
Experimental: Experimental group 3; Experimental group 3: Vicagrel 30mg loading followed by 7.5mg/day for 28 days	Drug: Vicagrel 7.5mg; Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days
Active Comparator: Control group; Control group: Clopidogrel 300mg loading followed by 75mg/day for 28 days	Drug: Clopidogrel 75mg; Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inhibition of platelet aggregation	Inhibition of platelet aggregation will be assessed by Verifynow System	28 days after treatment

Collaborators and Investigators

• Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2018
• Primary Completion (Actual): June 11, 2019
• Study Completion (Actual): July 28, 2019

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: VCP1-Ⅱ-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No