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Antiplatelet agent

vicagrel Capsules for Acute Coronary Syndrome

Phase 1
Waitlist Available
Led By Martin Kankam, MD
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

Study Summary

This trial will compare two drugs to see how they work in people with different metabolisms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day1-day31
This trial's timeline: 3 weeks for screening, Varies for treatment, and day1-day31 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
Assess the safety and tolerability of multiple doses of both drugs in each CYP2C19 phenotype group.

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
13 Previous Clinical Trials
1,090 Total Patients Enrolled
1 Trials studying Acute Coronary Syndrome
24 Patients Enrolled for Acute Coronary Syndrome
Martin Kankam, MDPrincipal InvestigatorAltasciences, Kansas City
2 Previous Clinical Trials
58 Total Patients Enrolled
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are partaking in this clinical experiment?

"Affirmative. Clinicaltrials.gov's records indicate that this clinical trial, which was initially posted on December 9th 2021, is actively recruiting individuals. 128 participants need to be recruited from two separate centres for the study to proceed as planned."

Answered by AI

Has the FDA authorized vicagrel Capsules for public consumption?

"Due to the limited clinical data available, our team at Power assigned vicagrel Capsules a score of 1 on its safety scale. This is because it is currently in Phase 1 trials and has not yet been proven safe or effective."

Answered by AI

What therapeutic uses are associated with vicagrel Capsules?

"Vicagrel Capsules are primarily utilized to prevent cardiovascular events. Patients with unstable angina pectoris, suitable for thrombolytic therapy and acute chest syndrome can also use this medication as treatment."

Answered by AI

Are there any historical precedents for administering vicagrel Capsules during clinical research?

"Vicagrel Capsules was first investigated at Institute of cardiovascular diseases,Fuwai hospital in 2007. To date, there are 363 completed studies and 55 active ones; many of these research projects take place in Kansas City, Missouri."

Answered by AI

Are there any available slots for enrolment in this clinical trial?

"Affirmative, the information hosted on clinicaltrials.gov suggests that this experiment is presently enrolling participants. It was initially posted on December 9th 2021 and most recently updated on July 4th 2022, and it requires 128 individuals to be enrolled from 2 research centres."

Answered by AI

Could I be a candidate to participate in this research effort?

"This clinical trial seeks to enrol 128 adults aged 18-65 with acute coronary syndrome. As is common in medical studies, there are several prerequisites that must be met: Ability and willingness of participants to provide informed consent; Male or female candidates between the specified ages; Weight requirements for males and females (50 kg/45 kg respectively) as well as BMI measurements within a certain range; CYP2C19 genotype assignment based on metabolizer type (ultra-rapid, rapid, normal, intermediate, poor); Compliance with study protocol guidelines; Acceptable physical examination results and vital signs test scores; Voluntary use of effective contraception"

Answered by AI

Does this trial accept participants aged over thirty?

"This clinical trial requires that potential participants are aged 18 or higher, but not more than 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PK/PD Study of Vicagrel and Clopidogrel in Healthy Subjects With Different CYP2C19 Metabolizers
2021. "PK/PD Study of Vicagrel and Clopidogrel in Healthy Subjects With Different CYP2C19 Metabolizers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05162053.
~38 spots leftby Apr 2025
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