Skip to content

Personalized Antiplatelet Therapy in CAD Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05174143
Enrollment
15000
Registered
2021-12-30
Start date
2016-12-31
Completion date
2021-10-31
Last updated
2021-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

CYP2C19

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.

Interventions

None listed

Sponsors

Xinjiang Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Mortality5 yearsAll-cause death and cardiac death
Net clinical adverse events5 yearsa composite of cardiac death, myocardial infarction (MI), revascularization, and bleeding (Bleeding Academic Research Consortium (BARC) definitions, type 2, 3, or 5),
bleeding events5 yearsBARC class 2 or higher bleeding events

Secondary

MeasureTime frameDescription
stent thrombosis5 yearsaccording to the Academic Research Consortium criteria
myocardial infarction5 yearsdefined in accordance with the universal definition proposed in 2007
major adverse cardiovascular and cerebrovascular events (MACCE)5 yearscardiac death, stroke, MI, stent thrombosis, or urgent revascularization
urgent revascularization5 yearswith persistent or increasing symptoms need to intervention
major adverse cardiovascular events (MACE)5 yearsdefined as cardiac death, cardiac death, MI, stent thrombosis, or urgent revascularization
stroke5 yearsincluding ischemic stroke and hemorrhage
all-cause death5 yearsall-cause death
cardiac death5 yearsdeath for cardiac cause

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026