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Allopurinol in Acute Coronary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03745729
Recruitment Status : Not yet recruiting
First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Xiang Cheng, Wuhan Union Hospital, China

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: allopurinol sustained-release capsules Drug: placebo capsules Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group Drug: allopurinol sustained-release capsules
allopurinol sustained-release capsules (0.3g), once a day, one pill at a time

Placebo Comparator: Control group Drug: placebo capsules
placebo sustained-release capsules, once a day, one pill at a time




Primary Outcome Measures :
  1. low attenuation plaque volume [ Time Frame: 12 months ]
    Changes of low attenuation plaque volume measured by coronary CTA


Secondary Outcome Measures :
  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, TNF-α and IL-6) [ Time Frame: 12 months ]
    Changes of inflammatory factors in plasma

  4. caspase-1 and SOD [ Time Frame: 12 months ]
    Changes of caspase-1 and SOD in plasma

  5. All-cause mortality [ Time Frame: 12 months ]
    All-cause mortality

  6. Readmission rate of acute coronary syndrome [ Time Frame: 12 months ]
    Readmission rate of acute coronary syndrome


Other Outcome Measures:
  1. Seattle angina questionnaire [ Time Frame: 12 months ]
    Seattle angina questionnaire

  2. European five dimensional health scale [ Time Frame: 12 months ]
    European five dimensional health scale

  3. Adverse events and serious adverse events [ Time Frame: 12 months ]
    Adverse events and serious adverse events



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. the people who understand and would sign the informed consent voluntarily;
  2. Aged 18 to 80 years old;
  3. hospitalized patients diagnosed as acute coronary syndrome in the past 1 months;

    1. hsCRP > 2mg/L;
    2. allopurinol allergy gene HLA-B5801 was negative.

Exclusion Criteria:

  1. history of coronary artery bypass grafting;
  2. allergy to allopurinol or any excipient;
  3. administration of allopurinol or other uric-acid-lowering drugs within 7 days before randomization;
  4. abnormal liver function (ALT >1.5 fold of the upper limit);
  5. renal dysfunction (creatinine clearance rate <45 ml/min);
  6. thrombocytopenia (PLT<100g/L);
  7. gout patients;
  8. uncontrolled infectious diseases in screening period;
  9. 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;
  10. 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;
  11. the history of surgery or interventional operation within 6 months before the screening period;
  12. patients with mental disorders such as anxiety or depression;
  13. pregnant women, lactating women or women of childbearing age who did not use effective contraceptive measures ;
  14. patients who participated in other clinical trials 3 months before the screening period;
  15. the researchers judged that patients were not suitable for this clinical trials.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745729


Contacts
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Contact: Miao Yu, Doctor +8613995562434 yumiaodavid@126.com

Sponsors and Collaborators
Wuhan Union Hospital, China

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Responsible Party: Xiang Cheng, Head of department of cardiology, Wuhan Union Hospital, China, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT03745729    
Other Study ID Numbers: ChiCTR1800019389
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Revman

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs