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Completed

NCT Number: NCT03745729

Allopurinol in Acute Coronary Syndrome

The pathogenesis of coronary heart disease is closely related to inflammation. IL-1 beta is an effective target for anti-inflammatory treatment of coronary heart disease. Allopurinol is a drug used for treating hyperuricemia and gout for many years. Recently, allopurinol has been proved to inhibit the production of NLRP3 in monocytes and reduce the level of IL-1beta, resulting in the decrease of TNF-alpha, IL-6 and CRP. Thus, in this study, the investigators aim to evaluate the efficacy and safety of allopurinol sustained-release capsules on improving the stability of coronary plaque in patients with acute coronary syndrome treated by conventional standardized therapy by the single-center, prospective, randomized, double-blind and controlled methods, which would provide new strategies for the treatment of coronary heart disease.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • the people who understand and would sign the informed consent voluntarily;
  • Aged 18 to 80 years old;
  • hospitalized patients diagnosed as acute coronary syndrome in the past 1 months;
  • hsCRP > 2mg/L;
  • allopurinol allergy gene HLA-B5801 was negative.

Exclusion criteria

  • history of coronary artery bypass grafting;
  • allergy to allopurinol or any excipient;
  • administration of allopurinol or other uric-acid-lowering drugs within 7 days before randomization;
  • abnormal liver function (ALT >1.5 fold of the upper limit);
  • renal dysfunction (creatinine clearance rate <45 ml/min);
  • thrombocytopenia (PLT<100g/L);
  • gout patients;
  • uncontrolled infectious diseases in screening period;
  • Thyroid dysfunction, moderate to severe anemia (hemoglobin < 90g/L), systemic lupus erythematosus, malignant hematopathy, leukopenia, asthma, inflammatory bowel disease and other immune diseases were found during the screening period;
  • Non-steroidal anti-inflammatory drugs, steroid hormone, immunomodulatory and chemotherapeutic drugs not included in the study protocol should be taken for a long time during the study period;
  • the history of surgery or interventional operation within 6 months before the screening period;
  • patients with mental disorders such as anxiety or depression;
  • pregnant women, lactating women or women of childbearing age who did not use effective contraceptive measures ;
  • patients who participated in other clinical trials 3 months before the screening period;
  • the researchers judged that patients were not suitable for this clinical trials.

Treatment and study plan

allopurinol sustained-release capsules

Drug

allopurinol sustained-release capsules (0.25g), once a day, one pill at a time

placebo capsules

Drug

placebo sustained-release capsules, once a day, one pill at a time

Primary outcomes

  1. low attenuation plaque volume

    Time frame: 12 months

    Changes of low attenuation plaque volume measured by coronary CTA

Secondary outcomes

  1. total plaque volume

    Time frame: 12 months

    Changes of total plaque volume measured by coronary CTA

  2. restructure index

    Time frame: 12 months

    Changes of restructure index measured by coronary CTA

  3. inflammatory factors hsCRP

    Time frame: 12 months

    Changes of inflammatory factors hsCRP in plasma

  4. All-cause mortality

    Time frame: 12 months

    All-cause mortality

  5. Readmission rate of acute coronary syndrome

    Time frame: 12 months

    Readmission rate of acute coronary syndrome

Other outcomes

  1. Adverse events and serious adverse events

    Time frame: 12 months

    Adverse events and serious adverse events

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Official study title

A Single-center, Prospective, Randomized, Double-blind, Controlled Trial for the Effect of Allopurinol Sustained-release Capsules on the Stability of Coronary Plaques in Patients With Acute Coronary Syndrome

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2018
Registry last updated
Sep 16, 2022

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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