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OpenTrials
Completed

NCT Number: NCT05174143

Personalized Antiplatelet Therapy in CAD Patients

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.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 5 years

    All-cause death and cardiac death

  2. Net clinical adverse events

    Time frame: 5 years

    a composite of cardiac death, myocardial infarction (MI), revascularization, and bleeding (Bleeding Academic Research Consortium (BARC) definitions, type 2, 3, or 5),

  3. bleeding events

    Time frame: 5 years

    BARC class 2 or higher bleeding events

Secondary outcomes

  1. all-cause death

    Time frame: 5 years

    all-cause death

  2. cardiac death

    Time frame: 5 years

    death for cardiac cause

  3. stent thrombosis

    Time frame: 5 years

    according to the Academic Research Consortium criteria

  4. myocardial infarction

    Time frame: 5 years

    defined in accordance with the universal definition proposed in 2007

  5. stroke

    Time frame: 5 years

    including ischemic stroke and hemorrhage

  6. urgent revascularization

    Time frame: 5 years

    with persistent or increasing symptoms need to intervention

  7. major adverse cardiovascular events (MACE)

    Time frame: 5 years

    defined as cardiac death, cardiac death, MI, stent thrombosis, or urgent revascularization

  8. major adverse cardiovascular and cerebrovascular events (MACCE)

    Time frame: 5 years

    cardiac death, stroke, MI, stent thrombosis, or urgent revascularization

Sponsors and collaborators

Lead sponsor

Xinjiang Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2021
Registry last updated
Dec 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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