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

NCT03758248 | Unknown DMC

• 1 other identifier: Gene Polymorphism
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Antiplatelet Therapy; CYP2C19 Polymorphism

Keywords

Genotype-guided therapy; CYP2C19 Polymorphism

Outcome Measures

Primary Outcomes (1)

• Patients with treatment-related major bleeding event as assessed by the Bleeding Academic Research Consortium (BARC) bleeding criteria

  The major bleeding event was a composite endpoint of BARC bleeding type 3 and 5), defined according to the BARC bleeding criteria, which was used widely in this field. BARC bleeding was defined as follows: BARC type 1, any bleeding that is not actionable; type 2, any overt, actionable sign of bleeding; type 3a, overt bleeding with a haemoglobin drop of 3-5 g/dL or any transfusion; type 3b, overt bleeding with a haemoglobin drop \>5 g/dL, requiring vasopressors, surgical intervention, or due to cardiac tamponade; type 3c, any intracranial or intraocular bleeding; and finally type 5, any bleeding resulting in death (type 4 was coronary artery bypass graft-related bleeding, which was excluded). Investigator will get all the information through regular return visit and telephone follow-up after discharge.

  up to 24 months

Secondary Outcomes (1)

• Major adverse cardiac events (MACE)

  up to 24 months

Interventions

CYP2C19 GENETIC

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

PCI patients in Beijing Anzhen Hospital from August 2018 to August 2019

You may qualify if:

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

You may not qualify if:

• Inability to provide written informed consent

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Gene polymorphism is measured by using whole blood in patients undergoing PCI.

MeSH Terms

Interventions

Cytochrome P-450 CYP2C19

Intervention Hierarchy (Ancestors)

Limonene Hydroxylases; Cytochrome P450 Family 2; Cytochrome P-450 Enzyme System; Cytochromes; Enzymes and Coenzymes; Mixed Function Oxygenases; Oxygenases; Oxidoreductases; Enzymes; Hemeproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Yujie Zhou, PhD,MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujie Zhou, PhD,MD

CONTACT

8613901330652; azzyj12@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 29, 2018
• Study Start: December 1, 2018
• Primary Completion: August 31, 2021
• Study Completion: September 30, 2021
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

CN (1)