Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
Conditions
Brief summary
This is a multi-center, randomized, double-blind, double-dummy, parallel-controled, phase III trial, aiming to evaluate the effectiveness and safety of long-term continuous administration of Vicagrel capsules in ACS patients undergoing PCI.
Interventions
DRUGVicagrel
Vicagrel loading followed by Maintenance dose
DRUGClopidogrel
Clopidogrel loading followed by Maintenance dose
Sponsors
Jiangsu vcare pharmaceutical technology co., LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients between 18 and 80 years old, with no gender restrictions. * Patients diagnosed with ACS and scheduled for PCI, including STEMI and NSTE-ACS (UA/NSTEMI). * Voluntarily sign the ICF and be able to follow the visit arrangements specified in the protocol during the trial period.
Exclusion criteria
* Expected survival time\<12 months; * Severe liver dysfunction (non heart disease induced ALT or AST\>3x ULN) and cirrhosis; * Pregnant or lactating women, or participants and their partners who plan to become pregnant during the trial period; * The researchers determined that other reasons were not suitable for participants in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of MACE | 6 month |
Countries
China
Contacts
CONTACTXiaojuan Lai
Outcome results
None listed