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

NCT06577519
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,000
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Lead sponsor
Jiangsu vcare pharmaceutical technology co., LTD
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Start date
2024-09-06
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Number of sites
1
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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.
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Short title
Efficacy and Safety Study of Vicagrel in Patients With Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2026-12-30
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First posted
2024-08-29
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Registry last updated
2026-07-27
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Primary completion date
2026-12-30
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Start date
2024-09-06
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Participants
1,000
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Participant count basis
Estimated
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Planned participants
1,000
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Jiangsu vcare pharmaceutical technology co., LTD
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06577519
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ClinicalTrials.gov ID
NCT06577519
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
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  1. The incidence of MACE

    Timeframe: 6 month

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • General Hospital of Northern Theater Command of Chinese PLAShenyang, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (1)