EUCTR2011-004265-32-NL进行中(未招募)不适用
eft Ventricular Thrombus Formation after Acute Myocardial Infarction - a randomized multi-center trial comparing 2 different anti-thrombotic regimens - LV thrombus after AMI
Academic Medical Center0 个研究点开始时间: 2011年11月23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
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.Suspected LV thrombus on echocardiography or routine MRI
- •2.Ongoing treatment with dual antiplatelet therapy (e.g. ASA and clopidogrel) at the time of
- •randomization
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •The following exclusion criteria are applied:
- •1Younger than 18
- •2Clinically or hemodynamically unstable
- •3Treatment with vitamin K antagonist prior to PCI or other expected indication for vitamin K antagonist treatment (e.g. atrium fibrillation) within the next 6 months
- •4Previous stroke or transient ischemic attack
- •5Scheduled for major surgery (including CABG) during the course of the study
- •6Active bleeding or high risk for bleeding contraindicating treatment with vitamin K antagonists
- •7Contra-indication for vitamin K treatment
- •8Chronic treatment with NSAIDs or COX-2 inhibitors for more than 4 days per week anticipated to continue during the study
- •9Congenital cardiac disease
- •10Presence of supraventricular or ventricular arrhythmias
- •11Expected candidate for ICD implantation with the next 6 months
- •12Severe renal impairment (estimated CrCl calculated by Cockcroft-Gault equation
- •= 30mL/min)
- •13Known or symptomatic brain disease (e.g. brain tumor)
- •14Women who are pregnant.
- •15Any contraindication for Contrast-Enhanced Magnetic Resonance Imaging i.e.:
- •cerebrovascular clips
- •known contrast allergy
- •claustrophobia
- •16Follow-up impossible (no fixed abode, etc)
研究者
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