11 results
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 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…
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…
The primary objective of the study is to determine the effect of tVNS on the innate immune response elicited by endotoxin (LPS) administration in healthy volunteers up to 24 hours after stimulation.Secondary objectives are to:- Determine effects of…
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,…
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).
To evaluate safety and feasibility of neoadjuvant chemotherapy-free regimen with trastuzumab, pertuzumab and tucatinib in stage II-III HER2-positive breast cancer.
Primary ObjectiveTo evaluate the antitumor activity of tucatinib given in combination with trastuzumab in subjects with previously treated, locally-advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) overexpressing/…
Primary* Compare progression-free survival (PFS) by investigator assessment per Response Evaluation Criteria inSolid Tumors (RECIST) v1.1 between treatment armsKey Secondary* Compare overall survival (OS) between treatment arms* Compare PFS by…
To evaluate the efficacy and safety of tucatinib in combination with trastuzumab and pertuzumab as maintenance therapy in subjects with advanced HER2+ breast cancer who have had prior treatment with a taxane, trastuzumab, and pertuzumab.
To evaluate the efficacy and safety of tucatinib in combination with trastuzumab and mFOLFOX6 in comparison to mFOLFOX6 given with or without either bevacizumab or cetuximab as first-line (1L) treatment in adults with HER2 positive (HER2+)…