Acute Coronary Syndrome
Conditions
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.
Interventions
DRUGallopurinol sustained-release capsules
allopurinol sustained-release capsules (0.25g), once a day, one pill at a time
DRUGplacebo capsules
placebo sustained-release capsules, once a day, one pill at a time
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| low attenuation plaque volume | 12 months | Changes of low attenuation plaque volume measured by coronary CTA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total plaque volume | 12 months | Changes of total plaque volume measured by coronary CTA |
| restructure index | 12 months | Changes of restructure index measured by coronary CTA |
| All-cause mortality | 12 months | All-cause mortality |
| Readmission rate of acute coronary syndrome | 12 months | Readmission rate of acute coronary syndrome |
| inflammatory factors hsCRP | 12 months | Changes of inflammatory factors hsCRP in plasma |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events and serious adverse events | 12 months | Adverse events and serious adverse events |
Countries
China
Outcome results
None listed