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NCT Number: NCT06577519

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

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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Key information

Conditions

Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI) Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

General Hospital of Northern Theater Command of Chinese PLA

Shenyang, Liaoning, 110015, China

Location status: Recruiting

Location contact

Yaling Han, M.D.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vicagrel

Drug

Vicagrel loading followed by Maintenance dose

clopidogrel

Drug

Clopidogrel loading followed by Maintenance dose

Primary outcomes

  1. The incidence of MACE

    Time frame: 6 month

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaojuan Lai

CONTACT

[email protected]

15358160458

Sponsors and collaborators

Lead sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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