Clinical trial NCT03745729: Allopurinol in Acute Coronary Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: low attenuation plaque volume
timeFrame: 12 months
Secondary outcomes:
measure: total plaque volume
timeFrame: 12 months
measure: restructure index
timeFrame: 12 months
measure: inflammatory factors hsCRP
timeFrame: 12 months
measure: All-cause mortality
timeFrame: 12 months
measure: Readmission rate of acute coronary syndrome
timeFrame: 12 months
Other outcomes:
measure: Adverse events and serious adverse events
timeFrame: 12 months
Locations:
city: Wuhan
country: China
facility: Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: