Allopurinol in Acute Coronary Syndrome
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
allopurinol sustained-release capsules
placebo capsules
Sponsored by

About this trial
This is an interventional treatment trial for Acute Coronary Syndrome
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment group
Control group
Arm Description
Outcomes
Primary Outcome Measures
low attenuation plaque volume
Changes of low attenuation plaque volume measured by coronary CTA
Secondary Outcome Measures
total plaque volume
Changes of total plaque volume measured by coronary CTA
restructure index
Changes of restructure index measured by coronary CTA
inflammatory factors hsCRP
Changes of inflammatory factors hsCRP in plasma
All-cause mortality
All-cause mortality
Readmission rate of acute coronary syndrome
Readmission rate of acute coronary syndrome
Full Information
NCT ID
NCT03745729
First Posted
November 9, 2018
Last Updated
September 14, 2022
Sponsor
Wuhan Union Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT03745729
Brief Title
Allopurinol in Acute Coronary Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
allopurinol sustained-release capsules
Intervention Description
allopurinol sustained-release capsules (0.25g), once a day, one pill at a time
Intervention Type
Drug
Intervention Name(s)
placebo capsules
Intervention Description
placebo sustained-release capsules, once a day, one pill at a time
Primary Outcome Measure Information:
Title
low attenuation plaque volume
Description
Changes of low attenuation plaque volume measured by coronary CTA
Time Frame
12 months
Secondary Outcome Measure Information:
Title
total plaque volume
Description
Changes of total plaque volume measured by coronary CTA
Time Frame
12 months
Title
restructure index
Description
Changes of restructure index measured by coronary CTA
Time Frame
12 months
Title
inflammatory factors hsCRP
Description
Changes of inflammatory factors hsCRP in plasma
Time Frame
12 months
Title
All-cause mortality
Description
All-cause mortality
Time Frame
12 months
Title
Readmission rate of acute coronary syndrome
Description
Readmission rate of acute coronary syndrome
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Adverse events and serious adverse events
Description
Adverse events and serious adverse events
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Revman
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Allopurinol in Acute Coronary Syndrome
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