Personalized Antiplatelet Therapy in CAD Patients

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT05174143
• Lead Sponsor: Xinjiang Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Primary Completion: 2021-06
• Study Completion: 2021-10
• Status Verified: 2021-12
• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2021-12-14
• Last Update Submitted: 2021-12-14
• Study First Posted: 2021-12-30
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15000

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;

4. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bleeding events	5 years	BARC class 2 or higher bleeding events
Mortality	5 years	All-cause death and cardiac death
Net clinical adverse events	5 years	a composite of cardiac death, myocardial infarction (MI), revascularization, and bleeding (Bleeding Academic Research Consortium (BARC) definitions, type 2, 3, or 5),

Secondary Outcome Measures

Name	Time	Method
all-cause death	5 years	all-cause death
cardiac death	5 years	death for cardiac cause
stent thrombosis	5 years	according to the Academic Research Consortium criteria
myocardial infarction	5 years	defined in accordance with the universal definition proposed in 2007
major adverse cardiovascular events (MACE)	5 years	defined as cardiac death, cardiac death, MI, stent thrombosis, or urgent revascularization
stroke	5 years	including ischemic stroke and hemorrhage
major adverse cardiovascular and cerebrovascular events (MACCE)	5 years	cardiac death, stroke, MI, stent thrombosis, or urgent revascularization
urgent revascularization	5 years	with persistent or increasing symptoms need to intervention