EUCTR2015-005566-33-DE进行中（未招募）1 期
APixaban versus PhenpRocoumon: Oral AntiCoagulation plus antiplatelet tHerapy in patients with Acute Coronary Syndrome and Atrial Fibrillation (APPROACH-ACS-AF) - APPROACH-ACS-AF
Klinikum der Universitaet Muenchen AoeR0 个研究点目标入组 400 人开始时间: 2016年2月4日最近更新:
适应症
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
- 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
- •Subjects will only be included in the study if they meet all of the following criteria:
- •- Signed written informed consent
- •- Patients with an ACS after successful percutaneous coronary intervention
- •- Indication for oral anticoagulation due to non-valvular atrial fibrillation or atrial flutter (CHA2DS2VASc score = 2)
- •- Males and Females, ages = 18
- •- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
- •- Women must not be breastfeeding
- •- WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs plus 30 days (duration of ovulatory cycle) post-treatment completion. However they must still undergo pregnancy testing.
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •Subjects will not be included in the study if any of the following criteria applies:
- •Age < 18 years
- •History of intracranial bleeding
- •Active bleeding
- •History of TIMI major bleeding according to TIMI and/or type =3b BARC criteria in the last 6 months
- •History of peptic ulcer in the last 6 months
- •Subjects with a history of a complicated or prolonged cardiogenic shock in the last two weeks prior to randomization. A complicated or prolonged cardiogenic shock is defined by a cardiogenic shock that required mechanical ventilation or the cardiovascular support with positive inotropic drugs (i.v. catecholamine) for =7 days
- •Planned major surgery during the study course with planned discontinuation of antithrombotic therapy
- •Expected life expectancy of less than a year and/or severe illness (e.g. malignancy)
- •Mechanical valve replacement
- •Valvular atrial fibrillation
- •Severe renal insufficiency (creatinine clearance < 30ml/min)
- •Severe liver insufficiency (Child-Pugh-class C) or elevated hepatic transaminases >2 times the upper limit of normal
- •Patient’s inability to fully comply with the study protocol
- •Known or persistent abuse of medication, drugs or alcohol reliable by the investigator in individual cases
- •Subjects with known contraindications to apixaban, phenprocoumon, clopidogrel or ASA treatment, which are hypersensitive to the drug substance or any component of the product
- •Relevant hematologic deviations: platelet count < 50 G/L or platelet count > 600 G/L
- •Current or planned pregnancy or nursing women, women 90 days after childbirth. Females of childbearing potential, who do not use and are not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently
研究者
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