Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)Phase 3NCT06577519
Efficacy and Safety Study of Vicagrel in Patients With Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
A Phase 3 study testing Vicagrel and Clopidogrel in people with Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
- What is being tested?
- Vicagrel and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2024to 30 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
General Hospital of Northern Theater Command of Chinese PLA
Shenyang, Liaoning, 110015
Yaling Han, M.D.
About this study
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
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.
- Being tested
- Vicagrel, Clopidogrel
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VicagrelDrug
Vicagrel loading followed by Maintenance dose
ClopidogrelDrug
Clopidogrel loading followed by Maintenance dose
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Vicagrel loading followed by Maintenance dose Receives: Drug: Vicagrel |
| Control group | Active comparator | Clopidogrel loading followed by Maintenance dose Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of MACE
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start6 Sep 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577519
- Sponsor's protocol ID
- VCP1-III-01
- Status last verified
- Jul 2026
- First submitted
- 28 Aug 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06577519
- Acronym / sponsor ID
- VCP1-III-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: VicagrelVicagrel loading followed by Maintenance dose |
| Control group | Active comparator | Drug: ClopidogrelClopidogrel loading followed by Maintenance dose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VicagrelVicagrel loading followed by Maintenance dose | Drug | Experimental group |
| ClopidogrelClopidogrel loading followed by Maintenance dose | Drug | Control group |
Primary outcome
The incidence of MACE
Time frame: 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
Related trials for Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
Not yet recruiting
IVUS-Guided Sirolimus-Coated Balloon Versus Sirolimus-Eluting Stent for De Novo Large Vessel Lesions in ACS
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
RecruitingObservational study
Cardiovascular-kidney-metabolic (CKM)-Guided Therapy for Patients After Acute Coronary Syndrome
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), Hypercholerolemia
Not yet recruitingPhase 4
Aspirin-Free Strategy After 3-6 Month Dual Antiplatelet Therapy in Acute Coronary Syndrome
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), Dual Anti-platelet Therapy
Not yet recruiting
Livalozet Versus High-intensity Statin in Older Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
RecruitingObservational study
Artificial Intelligence Based Timing, Infarct Size and Outcomes in Acute Coronary Occlusion Myocardial Infarction
Coronary Arterial Disease (CAD), Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vicagrel and Clopidogrel in people with Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaojuan Lai (15358160458, lai_xiaojuan@vcarepharmatech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of MACE (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.