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

NCT ID: NCT06577519

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-06

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental group

Vicagrel loading followed by Maintenance dose

Group Type EXPERIMENTAL

Vicagrel

Intervention Type DRUG

Vicagrel loading followed by Maintenance dose

Control group

Clopidogrel loading followed by Maintenance dose

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Clopidogrel loading followed by Maintenance dose

Interventions

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Vicagrel

Vicagrel loading followed by Maintenance dose

Intervention Type DRUG

Clopidogrel

Clopidogrel loading followed by Maintenance dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu vcare pharmaceutical technology co., LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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General Hospital of Northern Theater Command of Chinese PLA

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaojuan Lai

Role: CONTACT

15358160458

Facility Contacts

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Yaling Han, M.D.

Role: primary

Other Identifiers

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VCP1-III-01

Identifier Type: -

Identifier Source: org_study_id

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