EUCTR2021-003310-39-BE进行中（未招募）1 期
Effect of the antidiabetic drug DAPAgliflozin on the coronary macrovascular and MICROvascular function in type 2 diabetic patients (DAPAMICRO) - DAPAMICRO
CHU Saint Pierre0 个研究点目标入组 100 人开始时间: 2021年7月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.T2DM patients presenting with stable angina and a clinical indication for cardiac catheterization
- •2.T2DM patients with NSTEMI or unstable angina referred for cardiac catheterization
- •3.Demonstration of coronary lesion(s) with non-significant fractional flow reserve (FFR) values (>0.80), for which revascularisation is deferred
- •4.Agreement to practice an acceptable method of birth control for women of childbearing potential
- •5.Signed patient informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Age < 18 years old
- •2.Pregnancy or breastfeeding
- •3.Body mass index =45 kg/m2.
- •4.Creatinine clearance =45 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR).
- •5.Indication of liver disease, defined by serum levels of alanine amininotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal during screening or run-in phase
- •6.Uncontrolled hyperglycemia with glucose >240 mg/dL after an overnight fast
- •7.Stroke, or transient ischemic attack within 2 months prior to informed consent
- •8.Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
- •9.Any uncontrolled endocrine disorder except type 2 diabetes
- •10.Treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
- •11.Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at time of screening leading to unstable body weight
- •12.Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 2 years
- •13.Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
- •14.Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
- •15.Planned cardiac surgery or angioplasty within 3 months
- •16.Any clinical condition that would jeopardize patient safety while participating in this clinical trial (in Canada, this included current genito-urinal infection or genito-urinal infection within 2 weeks prior to informed consent)
- •17.Life expectancy < 3 years
研究者
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