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A placebo-controlled, double-blind, randomized trial to evaluate the effect of 300 mg of inclisiran sodium given as subcutaneous injections in subjects with Atherosclerotic cardiovascular disease (ASCVD) or ASCVD- risk equivalents and elevated low density lipoprotein cholesterol (LDL-C)

The primary objective of this study is to evaluate the effect of inclisiran treatment on:•LDL-C levels at Day 510•Time adjusted percent change in LDL-C levels from baseline between Day 90 and Day 540 levels. The secondary objectives of this study…

A placebo-controlled, double-blind, randomized trial to evaluate the effect of 300 mg of inclisiran sodium given as subcutaneous injections in subjects with Atherosclerotic cardiovascular disease (ASCVD) or ASCVD- risk equivalents and elevated low density lipoprotein cholesterol (LDL-C)

The primary objective of this study is to evaluate the effect of inclisiran treatment on:*LDL-C levels at Day 510*Time adjusted percent change in LDL-C levels from baseline between Day 90 and Day 540 levelsThe secondary objectives of this study are…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Ranolazine on Major Adverse Cardiovascular Events in Subjects with a History of Chronic Angina Who Undergo Percutaneous Coronary Intervention with Incomplete Revascularization

The primary objective of this study is to:• Evaluate the efficacy of ranolazine as compared with placebowhen used as part of standard medical therapy in chronicangina subjects with incomplete revascularization post percutaneous coronary intervention…

TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control

To compare the impact of adding sitagliptin to usual care vs. usual care without sitagliptin with regard to the risk of developing cardiovascular events.

A randomized, double-blind, placebo-controlled, parallel-group study to determine whether, in patients with type 2 diabetes at high risk for cardiovascular and renal events, aliskiren, on top of conventional treatment, reduces cardiovascular and renal morbidity and mortality

The purpose of this study is to determine whether, in patients with type II diabetes at high risk for cardiovascular and/or renal events, aliskiren at a target dose of 300 mg o.d. compared to placebo, on top of conventional treatment, reduces…

Evaluation of the Safety and Efficacy of Short-term A 002 Treatment in Subjects with Acute Coronary Syndromes

The objective of this study is to evaluate the safety and efficacy of A-002 when added to atorvastatin plus standard-of-care in subjects with an ACS. Specifically this study will examine the effect of treatment on morbidity and mortality as defined…

Protocol CKI-302 KW-3902IV in the treatment of subjects with acute heart failure syndrome
A multicenter, randomized, double-blind, placebo-controlled study of the effects of KW-3902 injectable emulsion on heart failure signs and symptoms and renal function in subjects with acute heart failure syndrome and renal impairment who are hospitalized for volume overload and require intravenous diuretic therapy

To evaluate the effect of KW-3902IV in addition to IV loop diuretic therapy on heart failure signs and symptoms, persistent renal dysfunction, morbidity and mortality, and safety in subjects hospitalized with acute heart failure syndrome, volume…

Protocol CKI-301 KW-3902IV in the treatment of subjects with acute heart failure syndrome
A multicenter, randomized, double-blind, placebo-controlled study of the effects of KW-3902 injectable emulsion on heart failure signs and symptoms and renal function in subjects with acute heart failure syndrome and renal impairment who are hospitalized for volume overload and require intravenous diuretic therapy

To evaluate the effect of KW-3902IV in addition to IV loop diuretic therapy on heart failure signs and symptoms, persistent renal dysfunction, morbidity and mortality, and safety in subjects hospitalized with acute heart failure syndrome, volume…

A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People Aliskiren Prevention Of Later Life Outcomes (APOLLO, CSPP100G2301)

Primary1. To determine whether treatment with an aliskiren-based regimen (in part combined with amlodipine or hydrochlorothiazide) compared to a non-aliskiren based regimen, both on top of non-study BP lowering agents where applicable, reduces the…

Echocardiography Guided Cardiac Resynchronization Therapy Clinical Investigation

The EchoCRT trial evaluates the effects of Cardiac Resynchronization Therapy (CRT) on mortality and morbidity of subjects with heart failure due to left ventricular systolic dysfunction, already receiving optimized HF medication, with a narrow QRS…

A multicenter, randomized, double-blind, placebo-controlled study of the effects of KW-3902 Injectable Emulsion on heart failure signs and symptoms, diuresis, renal function, and clinical outcomes in subjects hospitalized with worsening renal function and heart failure requiring intravenous therapy.

The objectives of this study are to evaluate the effect of KW-3902IV, in addition to standard therapy, on the proportion of worsening heart failure and worsening renal function after initiation of therapy through Day 7 or discharge, whichever occurs…

An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients with Atrial Fibrillation and Acute Coronary Syndrome and/or Percutaneous Coronary Intervention.

Dual Primary Objectives:* To determine if apixaban is noninferior to VKA (INR target range 2.0-3.0) on the combined endpoint of ISTHmajor or clinically relevant non-major bleeding in patients with NVAF who develop ACS or undergo PCI withplanned…

A Randomized, Double-blind, Placebo-controlled, Multicenter Long-term Safety and Tolerability Study of ETC 1002 in Patients with Hyperlipidemia at High Cardiovascular Risk Who are not Adequately Controlled by Their Lipid-Modifying Therapy

Primary Safety:* To evaluate the long-term safety and tolerability of ETC 1002 versus placebo in high cardiovascular (CV) risk patients with hyperlipidemia (with underlying heterozygous familial hypercholesterolemia [HeFH] and/or atherosclerotic…

A RaNdomized Double-blInd Placebo ConTrolled Study Characterizing THe Effects of PCSK9 Inhibition On Arterial Wall Inflammation in Patients With Elevated Lp(a) (ANITSCHKOW)

Patients with hyperlipidemie and an elevated Lp(a) will be asked to partipate in this study. This part potentially increases the risk of cardiovascular diseases. One of the reasons why Lp(a) is expected to increases this risk is that Lp(a)…

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function

This study is designed to demonstrate the CV and renal effects of sotagliflozin in patients with T2D, high CV risk, and moderate renal impairment. One of the major objectives of this study is to fulfill the regulatory mandate that any new therapy…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the
Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin
Amyloid Cardiomyopathy (ATTRibute-CM Trial)

Key PrimaryPart A• To determine the efficacy of acoramidis (AG10) in the treatment of subjects with symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM) by evaluating the difference between the acoramidis and placebo groups in the change from…

HELIOS-B: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy)

This study has been transitioned to CTIS with ID 2024-518318-25-00 check the CTIS register for the current data. Primary: • To evaluate the efficacy of vutrisiran compared to placebo on reducing all-cause mortality and cardiovascular (CV)-related…

Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes

To demonstrate that oral anticoagulation with the NOAC edoxaban is superior to current therapy (antiplatelet therapy or no therapy depending on cardio-vascular risk) to prevent stroke, systemic embolism, or cardiovascular death in patients with AHRE…

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 placebo-controlled, double-blind, randomized trial to evaluate the effect of 300 mg of inclisiran sodium given as subcutaneous injections in subjects with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C)

Primary :The primary objective is to evaluate the effect of inclisiran treatment on:* LDL-C levels at Day 510.* Time adjusted percent change in LDL-C levels from baseline after Day 90 up to Day 540 levelsSecondary:The secondary objectives are to…