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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019389
Enrollment
Unknown
Registered
2018-11-08
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute coronary syndrome

Interventions

Treatment group:Allopurinol Sustained-reease Capsules

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion 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; a) hsCRP > 2mg/L; b) allopurinol allergy gene HLA-B5801 was negative.

Exclusion criteria

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, hormones, 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 other clinical trials.

Design outcomes

Primary

MeasureTime frame
Changes of low attenuation plaque volume measured by coronary CTA;

Secondary

MeasureTime frame
Changes of total plaque volume measured by coronary CTA;Changes of restructure index measured by coronary CTA;Changes of inflammatory factors in plasma;Changes of caspase-1 and SOD in plasma;All-cause mortality;Readmission rate of acute coronary syndrome;

Countries

China

Contacts

Public ContactXiang Cheng

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

nathancx@126.com+86 15972061080

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026