AzTrials
AzTrials

Coronary Artery DiseaseNCT05174143

Personalized Antiplatelet Therapy in CAD Patients

An observational study of Coronary Artery Disease, run by Xinjiang Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Disease
How many people
15,000 participants
Where
No sites listed yet
Study dates
Dec 2016to Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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;
  • 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.

About this study

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

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.

Keywords
CYP2C19
Medical subject headings
Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    All-cause death and cardiac death

    Measured: 5 years

  2. 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),

    Measured: 5 years

  3. bleeding events

    BARC class 2 or higher bleeding events

    Measured: 5 years

Secondary outcomes (8)

  1. all-cause death

    all-cause death

    Measured: 5 years

  2. cardiac death

    death for cardiac cause

    Measured: 5 years

  3. stent thrombosis

    according to the Academic Research Consortium criteria

    Measured: 5 years

  4. myocardial infarction

    defined in accordance with the universal definition proposed in 2007

    Measured: 5 years

  5. stroke

    including ischemic stroke and hemorrhage

    Measured: 5 years

  6. urgent revascularization

    with persistent or increasing symptoms need to intervention

    Measured: 5 years

  7. major adverse cardiovascular events (MACE)

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

    Measured: 5 years

  8. major adverse cardiovascular and cerebrovascular events (MACCE)

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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2021
  2. Study startDec 2016
  3. Primary completionJun 2021
  4. Study completionOct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05174143
Sponsor's protocol ID
Y101310008
Status last verified
Dec 2021
First submitted
14 Dec 2021
Last updated
30 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39256835

  • 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.

    PubMed 39077558

  • 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.

    PubMed 39076545

  • 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.

    PubMed 39076386

  • 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.

    PubMed 38885991

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Xinjiang Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05174143, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in