Status:
RECRUITING
Efficacy and Safety Study of Vicagrel in Patients With Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
Lead Sponsor:
Jiangsu vcare pharmaceutical technology co., LTD
Conditions:
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06577519
Start Date
September 6 2024
End Date
December 30 2026
Last Update
October 1 2024
Active Locations (1)
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1
General Hospital of Northern Theater Command of Chinese PLA
Shenyang, Liaoning, China, 110015