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

Antiplatelet Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03758248
• Other study ID #: Gene Polymorphism
• Status: Recruiting
• Start date: December 1, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: December 2020
• Source: Beijing Anzhen Hospital
• Contact: Yujie Zhou, PhD,MD
• Phone: 8613901330652
• Email: azzyj12[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: September 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antiplatelet Therapy
• CYP2C19 Polymorphism

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Major adverse cardiac events (MACE)	A composite of death, myocardial infarction, stroke, stent thrombosis, and ischemia-driven revascularization	up to 24 months