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A randomized, double-blind, placebo-controlled, 4-period, two part cross-over study to evaluate the potential interaction effect between 4 mg/kg and 16 mg/kg sugammadex and enoxaparin or unfractionated heparin on anticoagulation activity in young healthy male volunteers

To investigate the potential of an interaction between 4 mg/kg and 16 mg/kg sugammadex and enoxaparin or UFH on anticoagulant activity in young healthy male volunteers.

A randomized, double-blind, placebo-controlled, 4-period cross-over drug-drug interaction study to evaluate the effect of sugammadex and aspirin on platelet aggregation and coagulation parameters in young healthy male volunteers

To investigate the potential of an interaction between 4 mg/kg sugammadex and aspirin on platelet aggregation using collagen-induced whole blood aggregometry in young healthy male volunteers.

Once-daily oral direct factor Xa rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. The Einstein-Extension study.

The purpose of this study is to show that the incidence of new thrombotic events during an additional 6 or 12 months of treatment with rivaroxaban is lower when compared to placebo and that the likely advantage of an extended effect is not offset by…

Medically Ill Patient Assessment of Rivaroxaban Versus Placebo IN Reducing Post-Discharge Venous Thrombo-Embolism Risk (MARINER)

Primary ObjectiveThe primary objective is to assess the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) and VTE-related death posthospital discharge in high-risk, medically ill…

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension

Primary objective* To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) at rest in comparison with placebo in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH).Secondary objectives* To…

An international, multicenter, randomized, double-blind, placebocontrolled
phase 3 trial investigating the efficacy and safety of rivaroxaban
to reduce the risk of major thrombotic vascular events in patients with
symptomatic peripheral artery disease undergoing lower extremity
revascularization procedures

The primary efficacy objective of the study is:* to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducingthe risk of major thrombotic vascular events (defined as MI, ischemic stroke, CVdeath, ALI, and major amputation of a…

A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA

This study has been transitioned to CTIS with ID 2023-503793-20-00 check the CTIS register for the current data. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who…

A randomized, double-blind, parallel group, placebo-controlled, multi-center study to assess the safety and tolerability of monthly subcutaneous administrations of a low and high dose cohort of Osocimab to ESRD patients on regular hemodialysis.

In this study researchers want to learn about the safety of drug Osocimab at low and high doses in adult participants with kidney disease undergoing regular dialysis. Patients with kidney disease undergoing regular dialysis are at high risk for…

Multicenter, randomized, placebo-controlled, double-blind, parallel group, dose-finding Phase 2 study to evaluate efficacy and safety of BAY 2433334 in patients following an acute non-cardioembolic ischemic stroke

The main objective of the study is to explore whether the addition of BAY 2433334 will lead to a dose response in reducing symptomatic strokes and covert brain infarcts and whether this is combined with no relevant increase in bleeding when given on…

Clinical Surveillance vs. Anticoagulation for Low-risk Patients with Isolated Subsegmental Pulmonary Embolism: A Multicenter Randomized Placebo-Controlled Non-Inferiority Trial

This study has been transitioned to CTIS with ID 2023-506943-40-00 check the CTIS register for the current data. The overall objective of this trial will be to evaluate the efficacy and safety of clinical surveillance without anticoagulation in low-…

A multi-centre, randomised, double-blind, placebo-controlled, Phase 2 study to investigate efficacy, safety and tolerability of SLN360 in participants with elevated lipoprotein(a) at high risk of atherosclerotic cardiovascular disease events.

The primary objective is to evaluate the effect of SLN360 on circulating levels of Lp(a) in participants with elevated Lp(a) at high risk of ASCVD events.The secondary objectives are to:• Evaluate safety and tolerability of SLN360 in participants…

A pilot study assessing the feasibility of a randomized controlled trial evaluating aspirin in postpartum women at risk of developing venous thromboembolism

The purpose of this pilot trial is to determine whether it is feasible to conduct a full multicentre randomized controlled trial (RCT) to determine whether low-dose aspirin (ASA) is efficacious and safe at preventing postpartum venous…

A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor twice daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients with Type 2 Diabetes Mellitus

The overall safety objective of this study is to assess the safety and tolerability of long-term therapy with ticagrelor compared to placebo in patients with T2DM at high risk of CV events, with or without background low-dose ASA therapy. Bleeding…

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Single Ascending Dose Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of DS-1040b when Added to Standard of Care Anticoagulation Therapy in Subjects with Acute
Submassive Pulmonary Embolism.

The primary objective of this study is to evaluate the safety and tolerability using bleeding as the primary endpoint. Secondarily, this study will serve as a proof-of concept by evaluating the effect that DS-1040b administration has on total…

A randomized, double-blind, placebo controlled, first in human study to investigate the safety, tolerability, and pharmacokinetic and pharmacodynamic response of SLN360 in subjects with elevated lipoprotein (a)

The primary objective is:i. To determine the safety and tolerability of single or multiple doses SLN360 in subjects with elevated Lp(a) levels. The secondary objectives include assessment of the following:i. PD effects of single and multiple doses…

Randomized placebo-controlled pilot study to determine the effect of probiotics on vitamin K status in renal transplant recipients

To investigate the effect of a daily sachet of probiotics for 12 weeks vs placebo on vitamin K status in renal transplant recipients.

The Rotterdam Antiplatelet Therapy in Vascular Patients Study

The objective of the proposed study is to evaluate if results as are written above, are to be extrapolated on high risk patients who underwent vascular surgery. In this group of patients, there is a substantial risk of 15-20% to die in the first…

Phase 1 trial of mutant proUK: HisproUK

The primary objective of the study is:* To evaluate the overall safety and tolerability related to systemic plasminogen activation of single doses of HisproUK (part 1) and sequential administration of tPA and HisproUK (part 2)The secondary…