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The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel

NCT03599284 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2019-09-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Clopidogrel 75mg

Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days

DRUG

Vicagrel 5mg

Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days

DRUG

Vicagrel 6mg

Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days

DRUG

Vicagrel 7.5mg

Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days

Sponsors & Collaborators

  • Jiangsu vcare pharmaceutical technology co., LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-30
Primary Completion
2019-06-11
Completion
2019-07-28

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03599284 on ClinicalTrials.gov