> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/efficacy-and-safety-study-of-vicagrel-in-patients-with-acute-febc693b-8e6e-492b-af21-d7d64c560adb
> Record changed: 2026-11-04

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

NCT06577519

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

Recruitment status

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

Participants

1,000

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

Lead sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

Start date

2024-09-06

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

## Title and summary

**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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Short title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

## Status and phase

**Control arm**

Active comparator

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Recruitment status**

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

## Dates

**Completion date**

2026-12-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**First posted**

2024-08-29

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Registry last updated**

2026-07-27

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Primary completion date**

2026-12-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Start date**

2024-09-06

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

## Size and sites

**Participants**

1,000

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Planned participants**

1,000

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Protocol amendments**

0

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Lead sponsor**

Jiangsu vcare pharmaceutical technology co., LTD

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

## Identifiers

**Registry ID**

NCT06577519

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**ClinicalTrials.gov ID**

NCT06577519

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Quadruple masking

**Masked roles**

Participants, Care providers, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

## Outcomes

### Primary outcomes

1. The incidence of MACE  
Timeframe: 6 month

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Maximum age**

80 Years

**Healthy volunteers**

No

### 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.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

## Sites

- General Hospital of Northern Theater Command of Chinese PLAShenyang, ChinaRecruiting

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577519)

## Related records

### Drugs (2)

- [Clopidogrel](https://trialight.com/data/asset/clopidogrel-04b37672-3c33-4ef3-8654-ae1df3cc9842.md)
- [Sumecigrel](https://trialight.com/data/asset/sumecigrel-f7a1d909-158a-4894-8345-c78bf02b536d.md)

### Lead sponsors (1)

- [Jiangsu vcare pharmaceutical technology co., LTD](https://trialight.com/data/company/jiangsu-vcare-pharmaceutical-technology-co-ltd-628e7aa8-68de-4d8e-8daa-cd0bd05c0f5a.md)

### Conditions (1)

- [Acute coronary syndrome](https://trialight.com/data/condition/acute-coronary-syndrome-3d7c2c1f-86ca-5a25-913a-6f9a7e95f989.md) Primary condition

### Targets (1)

- [P2RY12](https://trialight.com/data/target/p2ry12-507204ab-bea0-5561-8a51-7e9409c2e44d.md)

---

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