Personalized Antiplatelet Therapy in CAD Patients

NCT05174143 | Completed

• 1 other identifier: Y101310008
• Study Type: observational
• Target: 15,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Keywords

CYP2C19

Outcome Measures

Primary Outcomes (3)

• Mortality

  All-cause death and cardiac death

  5 years

• 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

• bleeding events

  BARC class 2 or higher bleeding events

  5 years

Secondary Outcomes (8)

• all-cause death

  5 years

• cardiac death

  5 years

• stent thrombosis

  5 years

• myocardial infarction

  5 years

• stroke

  5 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Combined with severe valvular heart disease;
• Combined with severe congenital heart disease;
• Combined hyperthyroidism, anemia and other high-powered heart disease; 4. With pulmonary heart disease;
• \. 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.

Sponsors & Collaborators

• Xinjiang Medical University: lead

Related Publications (5)

• Wu TT, Pan Y, Zheng YY, Wang ZL, Deng CJ, Wang S, Xie X. The U -shape relationship between free fatty acid level and adverse outcomes in coronary artery disease patients with hypertension: evidence from a large prospective cohort study. Lipids Health Dis. 2024 Sep 10;23(1):291. doi: 10.1186/s12944-024-02273-z.

  PMID: 39256835 DERIVED

• Wang SF, Wu TT, Zheng YY, Hou XG, Yang HT, Yang Y, Xie X. Serum Globulin to Albumin Ratio as a Novel Predictor of Adverse Clinical Outcomes in Coronary Artery Disease Patients Who Underwent PCI. Rev Cardiovasc Med. 2023 Oct 7;24(10):278. doi: 10.31083/j.rcm2410278. eCollection 2023 Oct.

  PMID: 39077558 DERIVED

• Pan Y, Wu TT, Deng CJ, Jiang ZH, Yang Y, Hou XG, Yan T, Wang S, Feng YJ, Zheng YY, Xie X. Association between the C-Reactive Protein-Albumin-Lymphocyte (CALLY) Index and Adverse Clinical Outcomes in CAD Patients after PCI: Findings of a Real-World Study. Rev Cardiovasc Med. 2024 Mar 25;25(4):111. doi: 10.31083/j.rcm2504111. eCollection 2024 Apr.

  PMID: 39076545 DERIVED

• Ning Y, Wang KY, Min X, Hou XG, Wu TT, Ma YT, Xie X. Cystatin C to Left Ventricular Ejection Fraction Ratio as a Novel Predictor of Adverse Outcomes in Patients with Coronary Artery Disease: A Prospective Cohort Study. Rev Cardiovasc Med. 2023 Sep 18;24(9):260. doi: 10.31083/j.rcm2409260. eCollection 2023 Sep.

  PMID: 39076386 DERIVED

• Wu TT, Pan Y, Zhi XY, Deng CJ, Wang S, Guo XX, Hou XG, Yang Y, Zheng YY, Xie X. Association between extremely high prognostic nutritional index and all-cause mortality in patients with coronary artery disease: secondary analysis of a prospective cohort study in China. BMJ Open. 2024 Jun 16;14(6):e079954. doi: 10.1136/bmjopen-2023-079954.

  PMID: 38885991 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: December 30, 2021
• Study Start: December 1, 2016
• Primary Completion: June 1, 2021
• Study Completion: October 1, 2021
• Last Updated: December 30, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share