29 results
The aim of this study is to evaluate whether adding edoxaban to aspirin following femoropoplitealendovascular intervention will enable maintenance of vessel patency and prevent restenosisrelative to current treatment with clopidogrel and aspirin.
The main purpose of this study is to determine the rate of treatment-free molecular remission (MMR=MR3.0) after 48 weeks following start of the TFR phase. The study further seeks to provide evidence that suspending nilotinib therapy in these…
Primary: To characterize the PK of nilotinib in pediatric patients with newly diagnosed CP Ph+ CML, with CP or AP Ph+ CML resistant / intolerant to imatinib and/or dasatinib, or with Ph+ ALL refractory/relapsed.Secondary:• To assess the safety and…
To evaluate the effect of real-life food consumption on the pharmacokinetics of nilotinib in CML patients
Ticagrelor, at steady state (i.e. after 30 days), will be associated to an improved endothelial function as compared to clopidogrel or prasugrel.
To estimate the bleeding risk with rivaroxaban, compared with ASA, in addition to a singleantiplatelet agent (clopidogrel or ticagrelor), in subjects with a recent ACS .
To determine in all-comers patients undergoing PCI under standardised treatment (including the BioMatrix family of drug-eluting stents and bivalirudin), whether treatment with 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor…
Primary* To compare the efficacy (Major Molecular Response, MMR, rate at 12 months) Secondary* To compare the rate of durable MMR at 24 months in patients with a MMR at 12 months* To compare the rate, time to and duration of complete cytogenetic…
1. To investigate the safety of omission of clopidogrel compared to a strategy using aspirin + clopidogrel during 1 year follow-up in patients without an indication for OAC after TAVI (Cohort A);2. To investigate the safety of omission of…
To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE).To assess the primary bleeding events (PBE) of…
To assess the effect of switching CML patients, who have been treated with imatinib *2 years and who have stable detectable molecular residual disease above 0.01% (IS), to the combination of Nilotinib and PegIFN, in terms of the proportion of…
To compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischaemic stroke in patients with established peripheral artery disease.
To study whether ticagrelor, added to acetylsalicylic acid, modulates the inflammatory response to the administration of lipopolysaccharide (LPS) in humans in vivo.
The primary objective of this study is to demonstrate non-inferiority by pharmacodynamic (PD) analysis of the prasugrel 5-mg maintenance dose (MD) in aspirin-treated subjects <60 kg with stable coronary artery disease (CAD) versus the…
To compare progression free survival (PFS) of nilotinib and imatinib when used as initial therapy of unresectable and/or metastatic GIST in patients either who have not received prior therapy with TKIs or who have recurrent GIST after stopping…
Primary objective:* To compare the clinical efficacy of nilotinib to DTIC, based on progression free survival (PFS), in the treatment of c-Kit mutated melanoma in patients who have not received prior therapy with TKIs.Key secondary objectives:* To…
PRIMARY OBJECTIVEThe primary objective of the study will be to determine the efficacy of 12 weeks of nilotinib treatment as measured by the non progression rate (Complete response + Partial Response + Stable disease according to Response Evaluation…
The aim of the current study is to confirm the CMR rates of nilotinib in newly diagnosed CML-CP patients in a pan-European population using the EUTOS (*European Treatment and Outcome Study for CML*) standardised molecular laboratories. Secondary…
To evaluate the CCyR rate at 12 months of nilotinib compared to imatinib in adult patients with Ph+ CML in CP who have a suboptimal cytogenetic response on imatinib.
Primary* To evaluate whether the efficacy of nilotinib is superior to the control arm (as measured by progression free survivalSecondary* To compare the response rate, and time to response, duration of response, and time to tumor progression of…