Vitamin-K-Antagonist and direct thrombin inhibitor Dabigatran for thrombus resolution in left ventricular thrombus after acute STEMI: an open label randomized controlled multicenter Phase-II study

Medical University Of Graz0 个研究点目标入组 116 人开始时间: 2023年9月12日最近更新: 2024年7月22日

试验速览

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•Patients diagnosed with STEMI undergoing PCI (percutaeous coronary intervention) and having the LAD (left anterior descending artery) as the culprit vessel, Clinical risk score for LV-Thrombus >2 points, Age 18 years or older, Informed consent has to be given in written form, eGFR > 30 ml/min/1.73m2

•Any other form of myocardial infarction (NSTEMI) than STEMI, Known intracardiac thrombus (including cardiac ear thrombi), Cirrhosis of the liver (Child A-C), Any contraindication to study drugs or auxiliary drugs, Any contraindication for an cardiac MRI (e.g. metal implants or non-certified pacemaker systems), Persons unable to give consent or cannot understand the purpose of the study (dementia, etc.), or should be excluded by investigator's decision, Persons who cannot take the study measures / tablets or have a questionable compliance, Persons with limited life expectancy (< 3 months), Active bleeding or any prior bleeding episode in the last seven days other than intracranial bleeding, Intracranial bleeding in the last 6 months, Known allergy to thrombin inhibitor dabigatran, Haemodynamic instability as defined by intravenous administration of catecholamine, calciumsensitizers or phosphodiesterase inhibitors, Pregnancy or Breastfeeding, Preexisting oral anticoagulant therapy (VKA or NOAC), eGFR < 30ml/min/1.73m2, Parallel, ongoing participation in another pharmacological trial

发起方

Medical University Of Graz