Bivalirudin versus Heparin in NST and ST-Evaluation myocardial infarction on modern antiplatelet therapy in SWEDEHEART (the VALIDATE - SWEDEHEART-trial) - VALIDATE-SWEDEHEART-trial

ppsala Clinical Research Center0 个研究点目标入组 6,000 人开始时间: 2012年12月17日最近更新: 2017年7月3日

适应症

试验速览

暂无简介。

•-Patients with a diagnosis of NSTEMI as judged by the physician in accordance with current guideline definitions (positive troponin) or
•patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of =0.2 mV in leads V2-V3 and/or =0.1 mV in other leads or a probable new-onset left bundle branch block.
•- PCI of culprit lesion is intended (therapeutic PCI, not primarily diagnostic PCI).
•- Ability to provide informed consent
•- Age 18 years or older
•- Treated with bolus dose of ticagrelor or prasugrel before start of PCI
•Age 18 years or older
•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 3000
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3000

•- Previous randomization in the VALIDATE-SWEDEHEART trial
•- Known terminal disease with life expectancy less than one year.
•- Patients with known ongoing bleeding
•- Patients with uncontrolled hypertension in the opinion of the investigator
•- Patients with known subacute bacterial endocarditis
•- Patients with known severe renal (GFR < 30 ml/min) and /or liver dysfunctions
•- Patients with known thrombocytopenia or thrombocyte function defects
•- Any other contraindication for the study medications
•- Heparin >5000U before arriving to PCI lab or >3000U given during angiography before randomization
•- GpIIb/IIIa-inhibitors have been given or are pre-planned to be given during the procedure.

发起方

ppsala Clinical Research Center