Allopurinol in the Treatment of Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease Treated by Either PCI or CABG: Pilot Study
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 主要终点
- hs-CRP
研究概览
简要总结
Atherosclerosis is a progressive disease of the arterial wall, arising from the combination of endothelial dysfunction and inflammation. This link is exacerbated in diabetic patients.
Uric acid is known to generate oxidative stress and it's elevated levels has been shown to be associated with cardiac hypertrophy, inflammation, myocardial fibrosis and diastolic dysfunction. Allopurinol inhibits xanthine oxidase, an enzyme that regulates uric acid production. In observational studies it has been shown to reduce ischemia, inflammation and improve coronary flow. The aim of this study is to see whether treatment with Allopurinol in patients diagnosed with multivessel disease and undergoing treatment with either percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) , will reduce markers of inflammation and improve quality of life and major adverse cardiovascular effects (MACE).
详细描述
This is a pilot study, PROBE design (prospective randomized open label blinded endpoints study), that will include 100 patients.
Patients will be recruited during their hospitalization in the cardiology department of Ichilov- Tel-Aviv Sourasky Medical Center.
It will include patients with known or newly diagnosed diabetes mellitus, hospitalized with diagnosis of acute coronary syndrome and multi-vessel coronary artery disease (CAD) that will be demonstrated by cardiac catheterization that the patients will undergo during their hospitalization in concordance with their diagnosis and practice guidelines.
The decision about intervention with either PCI or CABG will be accepted by a heart team after the initial demonstration of multi-vessel disease.
Study recruitment will take place either in the first 24 hours after PCI or before CABG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute Coronary Syndrome with positive troponin
- •Patients with known or newly diagnosed diabetes mellitus with HbA1c above 7% and below 10%
- •Patients above the age of 40
- •Stable Hemodynamic state (At least 12 hours from presentation with acute coronary syndrome)
- •Uric Acid > 6mg/dl or 355 micromol/l (males) and >5mg/dl or 297 Micromol/l (females)
排除标准
- •HbA1c below 7% or above 10%
- •Severe valvular insufficiency/Stenosis
- •Major surgery within 30 days
- •Any medical condition that would impair participation (e.g. progressive neurological disorders, mental illness)
- •Known intolerance/ current use of allopurinol/colchicine
- •Chronic inflammatory diseases: e.g. Lupus, rheumatoid arthritis, etc.
- •Current treatment with steroids, NSAID, chemotherapy or biologic medications
- •Extra-cardiac illness that is expected to limit survival to less than 2 years.
- •Past Cancer within the past 5 years (excluding BCC and SCC).
研究组 & 干预措施
PCI, standard treatment and Allopurinol
Patients diagnosed with multi vessel disease that after Heart team discussion underwent intervention by PCI and in addition to standard medical treatment, receive treatment with allopurinol.
干预措施: Allopurinol (Drug)
CABG standard treatment and Allopurinol
Patients diagnosed with multi vessel disease that after Heart team discussion underwent intervention by CABG and in addition to standard medical treatment, receive treatment with allopurinol.
干预措施: Allopurinol (Drug)
结局指标
主要结局
hs-CRP
时间窗: 3 months.
Change in inflammatory biomarkers
次要结局
- Uric acid levels(one month and 3 month)
- MACE(3 month)
- Endothelial function markers(3 month)
- functional status, quality of life: EuroQol EQ-5D questionnaire(3 month)
- Diastolic function(3 month)
- hs-CRP(one month)
- Heart rate variability(3 month)
- functional status and quality of life: the Seattle angina questionnaire(3 month)
- Reduction of peri-procedural myocardial infarction(72 hours)
研究者
michal roll
Director. Research & development, Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center