Personalized Antiplatelet Therapy in CAD Patients

Coronary Artery Disease Clinical Trial

Official title:

Personalized Antiplatelet Therapy According to CYP2C19 Genotype in Coronary Artery Disease: A Real World Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05174143
• Other study ID #: Y101310008
• Status: Completed
• Start date: December 2016
• Est. completion date: October 2021

Study information

• Verified date: December 2021
• Source: Xinjiang Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a prospective, no-randomized, single-center study performed on 15000 consecutive coronary artery patients from Dec. 2016 to Oct. 2021. All these patients were detected CYP2C19 genotype. The antiplatelet treatment was recorded according to the therapy actually adopted by the patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15000
• Est. completion date: October 2021
• Est. primary completion date: June 2021
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1.Aged >18 years old; 2. Coronary angiography confirmed that there was at least one coronary artery stenosis >70%; or the degree of stenosis of the left main artery stenosis >50%; 3. At least one clinical phenotype of coronary heart disease is present: stable angina or acute coronary syndrome 4.To be able to sign informed consent.

Exclusion Criteria:

1. Combined with severe valvular heart disease;

2. Combined with severe congenital heart disease;

3. Combined hyperthyroidism, anemia and other high-powered heart disease; 4. With pulmonary heart disease;

5. With hypertrophic obstructive cardiomyopathy; 6. Severe hypotension (SBP <90mmHg or DBP <60mmHg at enrollment); 7. Liver dysfunction (defined as ALT or total bilirubin is greater than the normal upper limit of 3 times); 8. Renal insufficiency (defined as serum creatinine greater than 1.5 times the normal upper limit); 9. High-risk bleeding patients, such as thrombocytopenia, blood diseases and other diseases; 10. active peptic ulcer and skin ulcers; 11. A patient who is allergic to clopidogrel, Ticagrelor, or aspirin; 12. Patients with a history of cardiogenic shock within two weeks; 13. pregnant and lactating women, during treatment can not be strict contraception of women of childbearing age; 14. In the past 3 months participated in other clinical researchers; 15. Persons who do not have legal or legal competence; 16. Any condition that the investigator considers unsuitable for participation in the clinical study.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xinjiang Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	All-cause death and cardiac death	5 years
Primary	Net clinical adverse events	a composite of cardiac death, myocardial infarction (MI), revascularization, and bleeding (Bleeding Academic Research Consortium (BARC) definitions, type 2, 3, or 5),	5 years
Primary	bleeding events	BARC class 2 or higher bleeding events	5 years
Secondary	all-cause death	all-cause death	5 years
Secondary	cardiac death	death for cardiac cause	5 years
Secondary	stent thrombosis	according to the Academic Research Consortium criteria	5 years
Secondary	myocardial infarction	defined in accordance with the universal definition proposed in 2007	5 years
Secondary	stroke	including ischemic stroke and hemorrhage	5 years
Secondary	urgent revascularization	with persistent or increasing symptoms need to intervention	5 years
Secondary	major adverse cardiovascular events (MACE)	defined as cardiac death, cardiac death, MI, stent thrombosis, or urgent revascularization	5 years
Secondary	major adverse cardiovascular and cerebrovascular events (MACCE)	cardiac death, stroke, MI, stent thrombosis, or urgent revascularization	5 years