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

Last updated: September 28, 2024
Sponsor: Jiangsu vcare pharmaceutical technology co., LTD
Overall Status: Active - Recruiting

Phase

3

Condition

Heart Disease

Coronary Artery Disease

Myocardial Ischemia

Treatment

Vicagrel

Clopidogrel

Clinical Study ID

NCT06577519
VCP1-III-01
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 inthe protocol during the trial period.

Exclusion

Exclusion Criteria:

  • Expected survival time<12 months;

  • Severe liver dysfunction (non heart disease induced ALT or AST>3x ULN) andcirrhosis;

  • Pregnant or lactating women, or participants and their partners who plan to becomepregnant during the trial period;

  • The researchers determined that other reasons were not suitable for participants inthis experiment.

Study Design

Total Participants: 1000
Treatment Group(s): 2
Primary Treatment: Vicagrel
Phase: 3
Study Start date:
September 06, 2024
Estimated Completion Date:
December 30, 2026

Connect with a study center

  • General Hospital of Northern Theater Command of Chinese PLA

    Shenyang, Liaoning 110015
    China

    Active - Recruiting

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