Vicagrel + Clopidogrel for Coronary Syndrome

No longer recruiting at 2 trial locations

Overseen By Xiaojuan Lai

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

Must not be taking: CYP inhibitors, CYP inducers

Disqualifiers: Smoking, Drug abuse, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 31 days

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to understand how different people process two antiplatelet medications, Vicagrel and Clopidogrel, by studying their effects on the body. It focuses on healthy individuals with different versions of the CYP2C19 gene, which affects how these drugs are metabolized. This trial suits individuals who know their specific CYP2C19 metabolizer status, such as poor or rapid, and do not smoke or regularly use substances like alcohol and certain drugs. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.

Do I need to stop my current medications to join the trial?

Yes, you will need to stop taking any prescription drugs, over-the-counter drugs, vitamins, or herbal medicines at least 14 days before starting the study medication.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that clopidogrel has been tested for safety in over 54,000 patients, with more than 21,000 monitored for at least a year. However, clopidogrel may increase the risk of serious bleeding during surgery or certain medical procedures and can harm organs like the liver and digestive system with long-term use.

For vicagrel, studies suggest that doses from 5 mg to 75 mg are generally safe and well-tolerated, with no major side effects reported. Vicagrel is a strong antiplatelet drug that helps prevent blood clots by targeting a specific part of the body. Overall, both treatments have demonstrated safety in various studies, but potential users should be aware of the specific risks involved. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore how vicagrel might be more effective than the standard clopidogrel, especially in people who metabolize drugs differently. Most treatments for blood clot prevention, like clopidogrel, rely on the body's ability to activate the drug, but not everyone does this efficiently due to genetic differences in the CYP2C19 enzyme. Vicagrel, on the other hand, is designed to bypass some of these genetic limitations, potentially offering more consistent and reliable blood thinning effects across various metabolizer types. This could lead to more personalized and effective treatment options for preventing blood clots.

What evidence suggests that this trial's treatments could be effective for different CYP2C19 metabolizers?

Research has shown that clopidogrel can reduce major heart problems, such as heart attacks, in patients who have undergone procedures like stent placements. However, it may not be as effective for individuals whose bodies do not process the drug efficiently. This trial will evaluate both clopidogrel and vicagrel, grouping participants based on their metabolizer status. Vicagrel, a promising drug that helps prevent blood clots, is generally well-tolerated. It might provide more consistent results than clopidogrel by bypassing genetic differences that affect drug processing. Early studies suggest vicagrel could be a strong alternative to clopidogrel, especially for individuals with certain genetic makeups. ^{5 6 7 8 9}

Who Is on the Research Team?

Yanhua Ding

Principal Investigator

Phase I Clinical Research Center of The First Hospital of Jilin University

Youngjun David Kim, MD

Principal Investigator

Altasciences Clinical, Los Angeles

Martin Kankam, MD

Principal Investigator

Altasciences, Kansas City

Are You a Good Fit for This Trial?

Inclusion Criteria

With normal or clinically insignificant abnormal results of physical examination and vital signs test;

Able and willing to give written informed consent before study, and fully understand the study content, process and possible adverse reactions;

Able to complete the study in compliance with the protocol;

Exclusion Criteria

Positive results from a screen for urine drug test (Morphine, marijuana);

Subjects were vaccinated within 4 weeks prior to screening, or planned to be vaccinated during the trial;

Consumption of any special diet (such as grapefruit, pitaya, mango, pomelo, etc.) or subjects have engaged strenuous exercise or any other factors affecting drug absorption, distribution, metabolism and excretion within 14 days prior to receiving study drug;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 7-day cross-dosing of vicagrel and clopidogrel between two cycles

31 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clopidogrel Tablets
• Clopidogrel Tablets（PLAVIX ）
• vicagrel Capsules

How Is the Trial Designed?

Group I: Ultra-rapid metabolizers group Experimental Treatment 2 Interventions

A 7-day cross-dosing of vicagrel and clopidogrel between two cycles

Group II: Rapid metabolizers group Experimental Treatment 2 Interventions

A 7-day cross-dosing of vicagrel and clopidogrel between two cycles

Group III: Poor metabolizers group Experimental Treatment 2 Interventions

A 7-day cross-dosing of vicagrel and clopidogrel between two cycles

Group IV: Normal metabolizers group Experimental Treatment 2 Interventions

A 7-day cross-dosing of vicagrel and clopidogrel between two cycles

Group V: Intermediate metabolizers group Experimental Treatment 2 Interventions

A 7-day cross-dosing of vicagrel and clopidogrel between two cycles

Who Is Running the Clinical Trial?

Jiangsu vcare pharmaceutical technology co., LTD

Lead Sponsor

Trials

20

Recruited

3,000+

Published Research Related to This Trial

Clopidogrel is significantly more effective than aspirin for preventing atherothrombotic events in patients with established atherosclerotic disease, as shown in the CAPRIE study.

In patients with acute coronary syndromes, clopidogrel provides substantial benefits over placebo, but adding aspirin to clopidogrel does not improve outcomes in patients with cerebrovascular disease, according to the MATCH trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clopidogrel: cardiologists' panacea or neurologists' headache? Bezerra, DC., Bogousslavky, J.[2009]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/circoutcomes.117.004194

Clinical Outcomes of Plavix and Generic Clopidogrel for ... At 1 year, 17.6% of patients prescribed Plavix and 17.9% of patients prescribed clopidogrel experienced the primary outcome (hazard ratio, 1.02; ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK470539/

Clopidogrel - StatPearls - NCBI Bookshelf When taken with a standard breakfast, the inhibition of ADP-induced platelet aggregation was reduced by less than 9%. The area under the curve ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S155383892500291X

pci patients: An updated systematic review and meta-analysis Clopidogrel is associated with reduction in major adverse cardiovascular events as compared to aspirin in post-PCI patients.

4. fda.gov fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fda-drug-safety-communication-reduced-effectiveness-plavix-clopidogrel-patients-who-are-poor

Reduced effectiveness of Plavix in patients who are poor ... In these patients, Plavix has less effect on platelets, and therefore less ability to prevent heart attack, stroke, and cardiovascular death. It ...

5. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2817471

Extended Clopidogrel Monotherapy vs DAPT in Patients ... Randomized clinical trials have demonstrated that adverse outcomes such as myocardial infarction (MI) and stent thrombosis are reduced with a ...

6. cdn.pfizer.com cdn.pfizer.com/pfizercom/products/material_safety_data/PZ01528.pdf

MATERIAL SAFETY DATA SHEET Releases to the environment should be avoided. Mobility, Persistence and. Degradability: Not readily biodegradable ( 4.07 % after 28 days). (Clopidogrel).

7. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9BRMY_PLAVIX_TAB_75MG.pdf

Safety Data Sheet Causes damage to organs (blood, liver, gastrointestinal tract) through prolonged or repeated exposure. Page 2. PLAVIX® (clopidogrel bisulfate) Film- ... This ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2016/020839s062s064lbl.pdf

PLAVIX (clopidogrel bisulfate) tablets, for oral use Plavix has been evaluated for safety in more than 54,000 patients, including over 21,000 patients treated for one year or more. The clinically important adverse ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/clopidogrel-oral-route/description/drg-20063146

Clopidogrel (oral route) - Side effects & dosage Clopidogrel may increase the risk of serious bleeding during a surgery, other medical procedures (eg, coronary stent procedure), or some kinds ...