Efficacy and Safety Study of Vicagrel in Patients With Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
Efficacy and Safety of Vicagrel in Patients With With Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI): a Multi-center, Randomized, Double-blind, Double-dummy , Parallel-controlled, Phase III Trial
Jiangsu vcare pharmaceutical technology co., LTD
1,000 participants
Sep 6, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria4
- 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.
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Interventions
Vicagrel loading followed by Maintenance dose
Clopidogrel loading followed by Maintenance dose
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06577519