Allopurinol in Acute Coronary Syndrome

NCT03745729 | Completed Phase 4

• 1 other identifier: ChiCTR1800019389
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• low attenuation plaque volume

  Changes of low attenuation plaque volume measured by coronary CTA

  12 months

Secondary Outcomes (5)

• total plaque volume

  12 months

• restructure index

  12 months

• inflammatory factors hsCRP

  12 months

• All-cause mortality

  12 months

• Readmission rate of acute coronary syndrome

  12 months

Other Outcomes (1)

• Adverse events and serious adverse events

  12 months

Study Arms (2)

Treatment group

EXPERIMENTAL

Drug: allopurinol sustained-release capsules

Control group

PLACEBO COMPARATOR

Drug: placebo capsules

Interventions

allopurinol sustained-release capsules DRUG

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

Treatment group

placebo capsules DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the people who understand and would sign the informed consent voluntarily;
• Aged 18 to 80 years old;
• hospitalized patients diagnosed as acute coronary syndrome in the past 1 months;
• hsCRP \> 2mg/L;
• allopurinol allergy gene HLA-B5801 was negative.

You may not qualify if:

• history of coronary artery bypass grafting;
• allergy to allopurinol or any excipient;
• administration of allopurinol or other uric-acid-lowering drugs within 7 days before randomization;
• abnormal liver function (ALT \>1.5 fold of the upper limit);
• renal dysfunction (creatinine clearance rate \<45 ml/min);
• thrombocytopenia (PLT\<100g/L);
• gout patients;
• uncontrolled infectious diseases in screening period;
• 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;
• 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;
• the history of surgery or interventional operation within 6 months before the screening period;
• patients with mental disorders such as anxiety or depression;
• pregnant women, lactating women or women of childbearing age who did not use effective contraceptive measures ;
• patients who participated in other clinical trials 3 months before the screening period;
• the researchers judged that patients were not suitable for this clinical trials.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of cardiology, Wuhan Union Hospital, China

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 19, 2018
• Study Start: March 1, 2019
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)