Efficacy and Safety Study of Vicagrel in Patients With Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
Phase 3
Recruiting
- Conditions
- Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
- Interventions
- Registration Number
- NCT06577519
- Lead Sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Vicagrel Vicagrel loading followed by Maintenance dose Control group Clopidogrel Clopidogrel loading followed by Maintenance dose
- Primary Outcome Measures
Name Time Method The incidence of MACE 6 month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
General Hospital of Northern Theater Command of Chinese PLA
🇨🇳Shenyang, Liaoning, China