Allopurinol in Acute Coronary Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: allopurinol sustained-release capsules
* Drug: placebo capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br> | Drug: allopurinol sustained-release capsules<br>* allopurinol sustained-release capsules (0.25g), once a day, one pill at a time<br>|
| Placebo Comparator: Control group<br> | Drug: placebo capsules<br>* placebo sustained-release capsules, once a day, one pill at a time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| low attenuation plaque volume | Changes of low attenuation plaque volume measured by coronary CTA | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total plaque volume | Changes of total plaque volume measured by coronary CTA | 12 months | 
| restructure index | Changes of restructure index measured by coronary CTA | 12 months | 
| inflammatory factors hsCRP | Changes of inflammatory factors hsCRP in plasma | 12 months | 
| All-cause mortality | All-cause mortality | 12 months | 
| Readmission rate of acute coronary syndrome | Readmission rate of acute coronary syndrome | 12 months |