Efficacy and Safety Study of Vicagrel in Patients With Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)

Jiangsu Vcare PharmaTech

Status and phase: Enrolling; Phase 3

Conditions: Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)

Treatments: Drug: Vicagrel; Drug: Clopidogrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT06577519

VCP1-III-01

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,000 participants in 2 patient groups

Experimental group

Experimental group

Description:

Vicagrel loading followed by Maintenance dose

Treatment:

Drug: Vicagrel

Control group

Active Comparator group

Description:

Clopidogrel loading followed by Maintenance dose

Treatment:

Drug: Clopidogrel