Allopurinol in Acute Coronary Syndrome

NCT ID: NCT03745729

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2022-07-15

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment group

Group Type: EXPERIMENTAL

allopurinol sustained-release capsules

Intervention Type: DRUG

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

Control group

Group Type: PLACEBO_COMPARATOR

placebo capsules

Intervention Type: DRUG

placebo sustained-release capsules, once a day, one pill at a time

Interventions

allopurinol sustained-release capsules

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

Intervention Type: DRUG

placebo capsules

placebo sustained-release capsules, once a day, one pill at a time

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Xiang Cheng

Head of department of cardiology, Wuhan Union Hospital, China

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

Other Identifiers

ChiCTR1800019389

Identifier Type: -

Identifier Source: org_study_id