NCT03758248

The Influence of Gene Polymorphism on Clinical Outcomes in Patients Undergoing PCI

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 12,000 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Dual antiplatelet therapy with aspirin and thienopyridines is an essential treatment in patients undergoing percutaneous coronary intervention (PCI). However, despite intensified antiplatelet treatment, some of the patients undergoing PCI develop thrombotic stent occlusion, suggesting incomplete platelet inhibition due to thienopyridine resistance. Some patients develop bleeding event because of the improper dosage and covariation. This observational study is designed for clarifying the Influence of gene polymorphism on clinical outcomes in patients undergoing PCI.

Detailed description

Patients undergoing PCI who received dual antiplatelet therapy with both aspirin (100mg) and P2Y12 inhibitors in standard dosage were enrolled. Investigators examined plasma biomarkers for platelet activation and DNA in those patients, and then analyzed the CYP2C19 genetic polymorphism to examine the influence of this genetic variation on the several biomarkers for platelet activation and bleeding event.

Conditions

• Antiplatelet Therapy
• CYP2C19 Polymorphism

Interventions

Type	Name	Description
GENETIC	CYP2C19	The CYP2C19 enzyme plays a vital role in the two bioactivation steps of clopidogrel leading to lower (CYP2C19\*17 carriers) or higher (CYP2C19\*2 carriers) risk of major adverse cardiovascular events.

Timeline

• Start date: 2018-12-01
• Primary completion: 2021-08-31
• Completion: 2021-09-30
• First posted: 2018-11-29
• Last updated: 2020-12-08

Locations

1 site across 1 country: China