Allopurinol in Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03745729
• Other study ID #: ChiCTR1800019389
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: July 15, 2022

Study information

• Verified date: September 2022
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• allopurinol sustained-release capsules
allopurinol sustained-release capsules (0.25g), once a day, one pill at a time
• placebo capsules
placebo sustained-release capsules, once a day, one pill at a time

Locations

Country	Name	City	State
China	Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events and serious adverse events	Adverse events and serious adverse events	12 months
Primary	low attenuation plaque volume	Changes of low attenuation plaque volume measured by coronary CTA	12 months
Secondary	total plaque volume	Changes of total plaque volume measured by coronary CTA	12 months
Secondary	restructure index	Changes of restructure index measured by coronary CTA	12 months
Secondary	inflammatory factors hsCRP	Changes of inflammatory factors hsCRP in plasma	12 months
Secondary	All-cause mortality	All-cause mortality	12 months
Secondary	Readmission rate of acute coronary syndrome	Readmission rate of acute coronary syndrome	12 months