NCT06577519

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_3

Timeline
8mo left

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Sep 2024Dec 2026

First Submitted

Initial submission to the registry

August 28, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

September 6, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

October 1, 2024

Status Verified

August 1, 2024

Enrollment Period

2.3 years

First QC Date

August 28, 2024

Last Update Submit

September 28, 2024

Conditions

Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)

Outcome Measures

Primary Outcomes (1)

  • The incidence of MACE

    6 month

Study Arms (2)

Experimental group

EXPERIMENTAL

Vicagrel loading followed by Maintenance dose

Drug: Vicagrel

Control group

ACTIVE COMPARATOR

Clopidogrel loading followed by Maintenance dose

Drug: Clopidogrel

Interventions

VicagrelDRUG

Vicagrel loading followed by Maintenance dose

Experimental group
ClopidogrelDRUG

Clopidogrel loading followed by Maintenance dose

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Northern Theater Command of Chinese PLA

Shenyang, Liaoning, 110015, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

methyl 2-(2-acetoxy-6,7-dihydrothieno(3,2-c)pyridin-5(4H)-yl)-2-(2-chlorophenyl)acetateClopidogrel

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Xiaojuan Lai

CONTACT

15358160458lai_xiaojuan@vcarepharmatech.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2024

First Posted

August 29, 2024

Study Start

September 6, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

October 1, 2024

Record last verified: 2024-08

Locations

CN(1)