Evaluating Vicagrel for patients with Acute Coronary Syndrome undergoing heart procedures
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
PHASE3 · Jiangsu vcare pharmaceutical technology co., LTD · NCT06577519
This study is testing if a new medication called Vicagrel can help people with Acute Coronary Syndrome who are having heart procedures feel better and stay safe compared to a standard treatment.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Jiangsu vcare pharmaceutical technology co., LTD (industry) |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06577519 on ClinicalTrials.gov |
What this trial studies
This phase III clinical trial is a multi-center, randomized, double-blind, double-dummy, parallel-controlled study designed to assess the efficacy and safety of Vicagrel capsules in patients diagnosed with Acute Coronary Syndrome (ACS) who are scheduled for Percutaneous Coronary Intervention (PCI). Participants will receive either Vicagrel or Clopidogrel as part of their treatment regimen. The study aims to determine the long-term benefits of Vicagrel in this patient population, focusing on both effectiveness and safety outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 who have been diagnosed with Acute Coronary Syndrome and are scheduled for a Percutaneous Coronary Intervention.
Not a fit: Patients with a life expectancy of less than 12 months or those with severe liver dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that improves outcomes for patients with Acute Coronary Syndrome undergoing PCI.
How similar studies have performed: Other studies have shown success with similar approaches in evaluating antiplatelet therapies in ACS patients, indicating that this area of research is both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shenyang, Liaoning
- General Hospital of Northern Theater Command of Chinese PLA — Shenyang, Liaoning, China (RECRUITING)
Study contacts
- Study coordinator: Xiaojuan Lai
- Email: lai_xiaojuan@vcarepharmatech.com
- Phone: 15358160458
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention