Clinical Trials Directory

Trials / Completed

CompletedNCT03599284

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
279 (actual)
Sponsor
Jiangsu vcare pharmaceutical technology co., LTD · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
DRUGVicagrel 5mgExperimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days
DRUGVicagrel 6mgExperimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days
DRUGVicagrel 7.5mgExperimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days
DRUGClopidogrel 75mgControl group : Clopidogrel 300mg loading followed by 75mg/day for 28 days

Timeline

Start date
2018-08-30
Primary completion
2019-06-11
Completion
2019-07-28
First posted
2018-07-26
Last updated
2019-09-23

Locations

27 sites across 1 country: China

Source: ClinicalTrials.gov record NCT03599284. Inclusion in this directory is not an endorsement.