Allopurinol in Acute Coronary Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: allopurinol sustained-release capsules; Drug: placebo capsules

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control group	Drug: placebo capsules; placebo sustained-release capsules, once a day, one pill at a time
EXPERIMENTAL: Treatment group	Drug: allopurinol sustained-release capsules; allopurinol sustained-release capsules (0.25g), once a day, one pill at a time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
low attenuation plaque volume	Changes of low attenuation plaque volume measured by coronary CTA	12 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events and serious adverse events	Adverse events and serious adverse events	12 months

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): July 15, 2022
• Study Completion (ACTUAL): July 15, 2022

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (ACTUAL): November 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Protective Agents; Antioxidants; Free Radical Scavengers; Gout Suppressants; Allopurinol
• Other Study ID Numbers: ChiCTR1800019389

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Revman

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No