Clinical trial NCT05174143: Personalized Antiplatelet Therapy in CAD Patients
Official title: Personalized Antiplatelet Therapy According to CYP2C19 Genotype in Coronary Artery Disease: A Real World Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: CYP2C19
Lead sponsor: Xinjiang Medical University
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were ≥18 years of age, and coronary angiography confirmed that at least one coronary artery stenosis was ≥ 70% or that the left main stenosis was ≥50% amenable to PCI.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: 5 years
measure: Net clinical adverse events
timeFrame: 5 years
measure: bleeding events
timeFrame: 5 years
Secondary outcomes:
measure: all-cause death
timeFrame: 5 years
measure: cardiac death
timeFrame: 5 years
measure: stent thrombosis
timeFrame: 5 years
measure: myocardial infarction
timeFrame: 5 years
measure: stroke
timeFrame: 5 years
measure: urgent revascularization
timeFrame: 5 years
measure: major adverse cardiovascular events (MACE)
timeFrame: 5 years
measure: major adverse cardiovascular and cerebrovascular events (MACCE)
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References: