15 results
The study hypothesis is that anticoagulation with bivalirudin for primary PCI in STEMI subjects with a 4 h infusion post-PCI will reduce infarct size compared with anticoagulation with UFH as assessed by CMR 5 days after the index event.The primary…
• To evaluate the tolerability and safety of ascending single oral doses of ACT-541468 in healthy male subjects.• To investigate the single oral dose pharmacokinetic (PK) and PD of ACT-541468 in healthy male subjects.• To investigate dose…
The objective of the study is to determine the non inferiority of TITANOX over EES and to determine the superiority of bivalirudin during 4 hours over bivalirudin during PCI in patients with ACS who are scheduled for primary PCI (STEMI) or for…
The primary objective of the study is to compare the efficacy of intravenous immunoglobulin product with the efficacy of antibiotic treatment in patients with recurrent respiratory infections and IgG-subclass deficiency and/or selective anti-…
To test the hypothesis that IVIG treatment diminish the risk of development of chronic disease, we designed a prospective clinical intervention study in children with newly diagnosed ITP.
The purpose of the trial is to show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in patients with STE-ACS, with an onset of symptoms of >20 minutes and <12 hours,…
A controlled trial to investigate whether high dose of intravenous immunoglobulin (IVIg) in addition to conventional heart failure therapy in patients with idiopathic cardiomyopathy and PVB19 persistence in the heart achieves improvement of cardiac…
1. Primary end point is achievement of a negative cross-match test with the donor kidney and transplantability.2. Secondary objectives are patient and graft survival, graft function as assessed by calculated creatinine clearance, proteinuria, the…
To determine whether a second IVIg course in GBS patients with a poor prognosis improves functional outcome after 4 weeks.
The objective of the BRAVO 2/3 study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR).
1) To demonstrate that trans-radial intervention as compared to femoral access site is associated to lower rate of the composite endpoint of death, MI or stroke within the first 30 days after randomization in acute coronary syndrome patients…
To evaluate the pharmacodynamic (PD) effects of the study treatments (ACT-541468 50 mg, ethanol at a blood level of 0.6 g/L for 5 h) as co-administration in 4 different combinations (ACT-541468 plus ethanol, ACT-541468 alone, ethanol alone, and…
Primary objective- To evaluate the effects of ACT-541468 on objective simulated driving performance, i.e., the standard deviation of the lateral position (SDLP), after single- and multiple dose administrations (i.e., on Day 1 and Day 4) in the…
There have been reports of a more serious course of COVID-19 infections in patients with a reduced immune system, such as patients with congenital immune disorders, (haematological) malignancies or patients taking medications that suppress the…
The primary aim is to examine whether early addition of IVIg to standard treatment with prednisone in patients with newly diagnosed myositis leads to superior clinical outcome after 12 weeks. Our secondary aims are to examine the effect the…