29 results
Objectives:To collect data on effect size for, and determine the feasibility of, a full scale multicentre RCT(Randomized Controlled Trial) that1. compares the efficacy and safety of NOACs with VKA treatment according to Dutchstandards, in VKA-…
The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the EMA in providing additional safety and efficacy data in approximately 150 patients with Ph+ CML whose disease had failed or who are otherwise not…
To assess the normalization (reversal) of coagulation assays upon administration of two dosages of Prothrombin Complex Concentratre (PCC, Cofact®) in healthy volunteers treated with either rivaroxaban or apixaban
Primary:-To assess the impact of educational programme on implementation phase adherence in patients taking apixaban for Stroke Prevention in Non-Valvular Atrial Fibrillation (SPAF) at 24 weeks.Secondary:-To identify predictive risk factors linked…
To evaluate the safety (bleeding) of 4 doses of apixaban as compared to placebo over a 26 week treatment period in selected subjects with recent (<=7 days) Acute Coronary Syndrome (ACS). To determine the optimal dose and regimen of apixaban…
To demonstrate that oral apixaban 2.5 mg BID is superior to subcutaneous (SC)enoxaparin 40 mg QD in reducing the event rate on the composite endpoint of adjudicated asymptomatic and symptomatic DVT, non-fatal PE and all-cause death through Day 12 of…
To evaluate the efficacy and safety of STS compared to placebo treatment on myocardial infarct size in patients presenting with STEMI and treated with PCI and in adjunction to optimal reperfusion therapy.
The objectives of the current study are:1. To allow long term bosutinib treatment in patients with chronic or advanced phases of Ph+ CML who received bosutinib in a previous Pfizer sponsored CML study (i.e., studies B1871006 and B1871008) and who…
to evaluate the safety and maximum tolerable dose of sodium thiosulfate in patients presenting with acute coronary syndrome undergoing coronary angiography via transradial approach, when given in combination with concomitant vasodilator drugs.
The primary objective of this study is to evaluate the proportion of patients achieving FXI inhibition * 80% at trough (Day 91) after monthly dosing at 3 dose levels of MAA868.
The aim of this study is to investigate the effect of body weight on the trough concentrations of DOACs. Eliquis®, Xarelto®, Lixiana® and Pradaxa®
Primary:To compare the efficacy of asciminib versus Investigator selected TKI with respect to the proportion of patients that are in Major Molecular Response at Week 48. To compare the efficacy of asciminib versus Investigator selected TKI, within…
Primary: To compare the Major Molecular Response (MMR) rate at 24 weeks of ABL001 versus bosutinibSecondary: To compare additional parameters of the efficacy of ABL001 versus bosutinib. Safety, tolerability.
Primary objective:• To assess, in healthy subjects, the pharmacodynamic (PD) properties of PCC in the presence and absence of selected DOACs.Secondary objectives:• To assess, in healthy subjects, the safety and tolerability of PCC in the presence…
To determine if the use of apixaban in patients with SCAF will reduce the incidence of stroke and systemic embolism compared to aspirin.
The primary objective of this study is to assess whether abelacimab is non-inferior to apixaban for preventing VTE recurrence at 6 months postrandomization in patients with cancer and recently diagnosed VTE. If noninferiority is demonstrated, then…
Primary: To assess the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response.
To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice
Primary: To compare the proportion of patients demonstrating Major Molecular Response (MMR) at 12 months (48 weeks) in the bosutinib arm with that of the imatinib arm in newly diagnosed Philadelphia chromosome positive (Ph+) chronic phase (CP)…
To demonstrate that anticoagulation with the direct factor Xa inhibitor apixaban is not less safe than VKA therapy in patients undergoing catheter ablation of non-valvular AF in the prevention of peri-procedural complications. The substudy involving…