EUCTR2007-003941-34-DE进行中（未招募）不适用
SAFETY AND EFFICACY OF SITAGLIPTIN PLUS GRANULOCYTE-COLONY STIMULATING FACTOR IN PATIENTS SUFFERING FROM ACUTE MYOCARDIAL INFARCTION - SITAGRAMI-Trial - SITAGRAMI-TRIA
Vorstand des Klinikums der Universität München - Grosshadern0 个研究点目标入组 100 人开始时间: 2008年7月4日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Be at least 18 years old, male or female
- •2.Have acute ST segment elevation myocardial infarction (typical chest pain of more than 30 minutes duration, presence of ST-segment elevation in at least two contiguous leads or left bundle-branch block)
- •3.Have regional wall motion abnormality (comprising hypo-, a- or dyskinesia) of at least one myocardial segment demonstrated with MRI.
- •4.Patients who are suitable for coronary angiography and angioplasty with stenting of the infarct related artery.
- •5.PCI with stenting within 2-24 hours after onset of STEMI.
- •6.Have the ability to understand the requirements of the study, and agree and be able to return for the required assessments.
- •7.Give a written 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Women of childbearing potential, pregnancy or being lactating.
- •2.Be unable to undergo percutaneous cardiac catheterisation
- •3.Have contraindications against magnetic resonance imaging (i.e. claustrophobia, permanent atrial fibrillation).
- •4.Previous enrolment in the present trial or administration of any study medication within the previous 30 days. Study drug is defined as any material (placebo or drug) dispensed under the provisions of a protocol.
- •5.Have other severe concurrent illness (e.g., active infection, malignancy).
- •6.Life expectancy of less than one year.
- •7.Have a history of alcohol or drug abuse within 3 months of admission or factors jeopardising follow-up.
- •Renal, hepatic, metabolic:
- •1.Moderate to severe renal impairment (Crea level >1.7 mg/dL or glomerular filtration rate <35 ml/min).
- •2.Diabetes type 1 patients.
- •3.Diabetic ketoacidosis.
- •4.Concomitant medications known to cause hypoglycemia, such as sulfonylureas or insulin.
- •5.Severe liver dysfunction.
- •Haematologic:
- •1.Malignant haematological diseases, i.e. chronic myeloic leukemia (CML) or myelodysplatic syndromes (MDS)
- •2.Severe congenital neutropenia with cytogenetic abnormalities
- •3.Known allergic reaction vs. Lenograstim
- •Cardiovascular:
- •1.Acute cardiogenic shock
- •2.Cardiomyopathy with an ejection fraction below 0.25 (i.e. ischemic or dilated cardiomyopathy resulting in congestive heart failure)
- •3.Infective endocarditis
- •4.Factors contraindicating cardiac catheterisation (e.g. severe allergy against iodine, severe thyroid disease)
- •5.Planned operative revascularisation
- •6.Prior thrombolysis
- •7.Left ventricular thrombus
- •8.Severe cardiac arrhythmias (i.e. malignant sustained or non-sustained ventricular tachycardia or ventricular fibrillation).
- •1. Acute massive pulmonary infiltrations
- •2. History of pneumonia in the last 4 weeks
- •1.Therapy with immunosuppressants, cytostatics, corticoids.
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