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

NCT ID: NCT03758248

Last Updated: 2020-12-08

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

UNKNOWN

Total Enrollment

12000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-09-30

Brief Summary

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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

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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

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Antiplatelet Therapy CYP2C19 Polymorphism

Keywords

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Genotype-guided therapy CYP2C19 Polymorphism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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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.

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

1. The patients undergoing PCI
2. More than 18 years old
3. Treated with aspirin and P2Y12 inhibitors (clopidogrel or ticagrelor)

Exclusion Criteria

Inability to provide written informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yujie Zhou

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yujie Zhou, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

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Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yujie Zhou, PhD,MD

Role: CONTACT

Phone: 8613901330652

Email: [email protected]

Facility Contacts

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Yujie Zhou, MD, PhD

Role: primary

Yujing Cheng, MD

Role: backup

Other Identifiers

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Gene Polymorphism

Identifier Type: -

Identifier Source: org_study_id