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Antiplatelet agent
PK/PD Study of Vicagrel and Clopidogrel in Healthy Subjects With Different CYP2C19 Metabolizers
Phase 1
Waitlist Available
Led By Yanhua Ding
Research Sponsored by Jiangsu vcare pharmaceutical technology co., LTD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day1-day31
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This trial is testing two blood-thinning medications, Vicagrel and Clopidogrel, in healthy people who process these drugs differently. The goal is to see how well these medications work in preventing blood clots. Vicagrel is a new medication developed to address the limitations of Clopidogrel.
Eligible Conditions
- Acute Coronary Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day1-day31
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day1-day31
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Area under the curve over a dosing interval(AUC0-tau)
Inhibition of platelet aggregation [IPA] evaluated in healthy subjects to treatment with either vicagrel or clopidogrel
Platelet reactivity index [PRI] evaluated in healthy subjects to treatment with either vicagrel or clopidogrel
+1 moreAwards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Ultra-rapid metabolizers groupExperimental Treatment2 Interventions
A 7-day cross-dosing of vicagrel and clopidogrel between two cycles
Group II: Rapid metabolizers groupExperimental Treatment2 Interventions
A 7-day cross-dosing of vicagrel and clopidogrel between two cycles
Group III: Poor metabolizers groupExperimental Treatment2 Interventions
A 7-day cross-dosing of vicagrel and clopidogrel between two cycles
Group IV: Normal metabolizers groupExperimental Treatment2 Interventions
A 7-day cross-dosing of vicagrel and clopidogrel between two cycles
Group V: Intermediate metabolizers groupExperimental Treatment2 Interventions
A 7-day cross-dosing of vicagrel and clopidogrel between two cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
vicagrel Capsules
2021
Completed Phase 1
~130
Clopidogrel
FDA approved
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Jiangsu vcare pharmaceutical technology co., LTDLead Sponsor
18 Previous Clinical Trials
2,761 Total Patients Enrolled
2 Trials studying Acute Coronary Syndrome
1,024 Patients Enrolled for Acute Coronary Syndrome
Yanhua DingPrincipal InvestigatorPhase I Clinical Research Center of The First Hospital of Jilin University
13 Previous Clinical Trials
1,570 Total Patients Enrolled
1 Trials studying Acute Coronary Syndrome
24 Patients Enrolled for Acute Coronary Syndrome
Youngjun David Kim, MDPrincipal InvestigatorAltasciences Clinical, Los Angeles
Martin Kankam, MDPrincipal InvestigatorAltasciences, Kansas City
3 Previous Clinical Trials
122 Total Patients Enrolled
yanhua dingPrincipal InvestigatorThe First Hospital of Jilin University
1 Previous Clinical Trials
138 Total Patients Enrolled