EUCTR2015-000239-34-AT进行中（未招募）1 期
T-proBNP Selected PreventiOn of cardiac eveNts in a populaTion of dIabetic patients without A history of Cardiac disease;a prospective randomized trial - PONTIAC II
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Type-2 diabetes mellitus for at least six months,
- •2)= 18 years of age, men or female,
- •3)Written informed consent to participate in the study and ability to comply with all requirements.
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •1)History of hypersensitivity to any of the drugs investigated as well as known or suspected contraindications to the study drugs or previous history of intolerance to high dose of RAAS-antagonists or beta-blocker in the absence of any other blood pressure lowering drugs.
- •2)Patients already receiving a maximum dose of RAAS-antagonists or beta-blocker.
- •3)Creatinine > 2.5mg/dl.
- •4)Symptomatic hypotension and/or systolic blood pressure (SBP) < 100mmHg at visit 1.
- •5)Symptomatic bradycardia and/or heart rate (HR) < 60bpm at visit 1.
- •6)Signs of cardiac disease in the electrocardiogram such as atrial fibrillation; ST-T abnormalities or a bundle branch block/ higher degree AV block.
- •7)Abnormal echocardiography, defined as low ejection fraction < 50%; wall motion abnormalities suggesting coronary artery disease (CAD), significant valve dysfunction > grades I.
- •8)Coronary artery disease, defined by a history of myocardial infarction, known coronary stenosis > 70% detected either by angiography or by CT-scan, significant defects in myocardial scintigraphy or positive stress-test echocardiography.
- •9)A disease other than diabetes lowering the patient’s life expectancy to less than two years.
- •10)Chronic infections or malignancies.
- •11)Systemic treatment with corticosteroids.
- •12)Renal replacement therapy.
- •13)Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, and oral), and double-barrier methods (if accepted by local regulatory authority and ethics committee). Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
- •14)Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human Chorionic Gonadotropin (hCG) laboratory test ( > 5mIU/ml).
- •15)History of noncompliance to medical regimes and patients who are considered potentially unreliable.
- •16)Current double blind treatment in diabetic trials.
- •17)Participation in an investigational drug study at the time of enrollment or within the past 90 days.
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