2024-517610-15-00招募中3 期
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of Allopurinol on the Risk of Cardiovascular Events in Patients With High and Very High Cardiovascular Risk, Including the Presence of Long-COVID Syndrome.
Uniwersytet Medyczny Im. Karola Marcinkowskiego W Poznaniu14 个研究点 分布在 1 个国家目标入组 1,116 人开始时间: 2024年12月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,116
- 试验地点
- 14
- 主要终点
- Occurrence of a major cardiovascular event (MACE) such as all cause death, cardiac death, stroke/TIA, acute coronary syndrome, coronary artery angioplasty or revascularization, peripheral arterial angioplasty, hospitalization for unstable angina, or worsening heart failure (hospitalization and stay in the emergency room / Hospital Emergency Department due to heart failure, the need for intravenous loop diuretic and/or doubling the dose of oral loop diuretic).
研究概览
简要总结
In patients with very high and high cardiovascular risk, the use of allopurinol will reduce cardiovascular risk, in the entire study population and in the group over 60 years of age.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age: between 40 and 70 years old
- •Giving informed consent to participate in the study
- •Serum uric acid above 5mg/dl within the last 6 months for screening
- •At least one of the criteria for very high or high cardiovascular risk: a. calculated 10-year risk of death from cardiovascular causes according to SCORE2 >2.5% for patients <50 years of age or ≥5% for patients ≥50 years of age b. documented occurrence of cardiovascular diseases (cerebrovascular disease: ischemic stroke, intracerebral bleeding, TIA; heart failure regardless of the etiology NYHA I - II, peripheral arterial disease PAD, atrial fibrillation (de novo or ever in history) c. diabetes or hypertension complicated by organ damage: i. increase in vascular stiffness: pulse pressure ≥ 60 mmHg, and/or cervicofemoral pulse wave velocity > 10 m/s ii. features of left ventricular hypertrophy on echocardiography or electrocardiography iii. elevated albumin-creatinine ratio in the urine sample (30-300 mg/g) iv. ankle-brachial index < 0.9.
排除标准
- •Taking allopurinol, febuxostat or other hypouricemic drugs within the last 6 months for screening.
- •Active neoplastic process or neoplastic disease in the last 5 years, excluding locally malignant neoplasms.
- •Uncontrolled hypertension (mean value ≥ 180/110 mmHg on the 7th day preceding the screening visit) in home measurements despite the use of antihypertensive drugs.
- •Renal failure with renal filtration rate eGFR <30 ml/min/ 1.73 m2 (according to recommendations of 2009 CKD-EPI G3b, G4 and G5).
- •Hypothyroidism or hyperthyroidism not in a euthyroid state.
- •Confirmed ischemic heart disease (defined as: history of AMI, myocardial revascularization or or the occurrence of angina symptoms accompanied by atherosclerotic changes in coronary vessels > 50% detected in computed tomography or coronary angiography).
- •Any condition or circumstance that, in the investigator’s judgment, could interfere with conduct of the study per protocol or with obtaining written informed consent, e.g., alcohol, drug, or other substance abuse or dependence.
- •Heart failure in class III and IV according to NYHA
- •Taking preparations: azathioprine, mercaptopurine, cyclosporine.
- •Participation in another clinical trial on a medicinal product or medical device within the last 3 months or 5 half-lives, whichever is longer
- •Diagnosed liver cirrhosis regardless of etiology.
- •Aspartate and/or alanine transaminase activity exceeding 3 times the upper limit of normal during the screening period
- •Contraindications to taking allopurinol preparation
- •Women who are pregnant, lactating or planning to become pregnant during the study.
- •Hormone therapy containing estrogens.
结局指标
主要结局
Occurrence of a major cardiovascular event (MACE) such as all cause death, cardiac death, stroke/TIA, acute coronary syndrome, coronary artery angioplasty or revascularization, peripheral arterial angioplasty, hospitalization for unstable angina, or worsening heart failure (hospitalization and stay in the emergency room / Hospital Emergency Department due to heart failure, the need for intravenous loop diuretic and/or doubling the dose of oral loop diuretic).
Occurrence of a major cardiovascular event (MACE) such as all cause death, cardiac death, stroke/TIA, acute coronary syndrome, coronary artery angioplasty or revascularization, peripheral arterial angioplasty, hospitalization for unstable angina, or worsening heart failure (hospitalization and stay in the emergency room / Hospital Emergency Department due to heart failure, the need for intravenous loop diuretic and/or doubling the dose of oral loop diuretic).
次要结局
- Individual MACE components alone or in combination
- Hospitalisation for reasons other than the primary endpoint.
- The assessment of the progression and/or development of organ complications and the development and/or progression of atherosclerosis including: echocardiography; the assessment of the incidence of atrial fibrillation in an electrocardiographic examination ; assessment of abdominal aorta diameter in uultrasound examination; the assessment of the intima-media complex and atherosclerotic plaques in the Doppler ultrasound of the carotid arteries; the assessment of the ankle-brachial index;
- The occurrence of long-COVID-19 symptoms.
- The assessment of treatment efficacy: the attainment of target serum uric acid levels of 5 mg/dL or 5.5 mg/dL depending on baseline values.
- The assessment of other laboratory parameters: estimated glomerular filtration rate (eGFR), albumin-to-creatinine ratio, urinary albuminuria; HbA1c; lipid profile; plasma C reactive protein concentrations; activity of aspartate and alanine transaminases (AspAT, AlAT).
- The assessment of the frequency of side effects.
- The assessment of changes in participants’ CVs based on the Systematic Coronary Risk Evaluation (SCORE) 2 scale
研究者
Sponsor Representative
Scientific
Uniwersytet Medyczny Im. Karola Marcinkowskiego W Poznaniu
研究点 (14)
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