Allopurinol in Acute Coronary Syndrome

Phase 4

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: allopurinol sustained-release capsules; Drug: placebo capsules

• Registration Number: NCT03745729
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-09
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-19
• Study Start: 2019-03-01
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-15
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	allopurinol sustained-release capsules	-
Control group	placebo capsules	-

Primary Outcome Measures

Name	Time	Method
low attenuation plaque volume	12 months	Changes of low attenuation plaque volume measured by coronary CTA

Secondary Outcome Measures

Name	Time	Method
total plaque volume	12 months	Changes of total plaque volume measured by coronary CTA
Readmission rate of acute coronary syndrome	12 months	Readmission rate of acute coronary syndrome
restructure index	12 months	Changes of restructure index measured by coronary CTA
All-cause mortality	12 months	All-cause mortality
inflammatory factors hsCRP	12 months	Changes of inflammatory factors hsCRP in plasma

Trial Locations

Locations (1)

Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China