Efficacy and Safety Study of Vicagrel in Patients With Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vicagrel, Clopidogrel.
- Who it may be relevant to
- Registry conditions: Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug Vicagrel
Vicagrel loading followed by Maintenance dose - Drug Clopidogrel
Clopidogrel loading followed by Maintenance dose
Primary outcome measures
- The incidence of MACE [Time frame: 6 month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- General Hospital of Northern Theater Command of Chinese PLA — Shenyang
Identifiers
NCT: NCT06577519 · VCP1-III-01