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Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy

2014-08-27 03:12:38 | BioPortfolio

Summary

Primary Objective:

- Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation (AF) and additional risk factors

Secondary Objective:

- Demonstrate the efficacy of Dronedarone in preventing cardiovascular death

Description

All patients are followed until a Common Study End Date that will be anticipated based on the projected blind number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death). The follow-up duration per patient should range between 3 months (last patient) and 3 years (first patient).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Atrial Fibrillation

Intervention

Dronedarone (SR33589), placebo

Status

Not yet recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:38-0400

Clinical Trials [701 Associated Clinical Trials listed on BioPortfolio]

EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)

To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial f...

Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.

European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure

The purpose of this study is to assess the efficacy, tolerability and safety of dronedarone versus placebo in patients with symptomatic congestive heart failure (CHF) and left ventricular...

Dronedarone in Pacemakers Patients With Paroxysmal Atrial Fibrillation

The purpose of this study is to accurately investigate the efficacy of dronedarone in maintaining sinus rhythm and decreasing AFB in patients with paroxysmal atrial fibrillation as compare...

Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers

The primary Objective of this study is to: - Evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (percent of time in which a subject is in AF) based on electrogram (EGM...

PubMed Articles [1944 Associated PubMed Articles listed on BioPortfolio]

Dronedarone produces early regression of myocardial remodelling in structural heart disease.

Left ventricular hypertrophy (LVH) in hypertension is associated with a greater risk of sustained supraventricular/atrial arrhythmias. Dronedarone is an antiarrhythmic agent that was recently approved...

Prophylactic amiodarone vs dronedarone for prevention of perioperative arrhythmias in offpump coronary artery bypass grafting: A pilot randomized controlled trial.

The aim of this study was to compare the effects of prophylactic dronedarone and amiodarone in prevention of arrhythmias during and following off-pump coronary artery bypass grafting (OPCAB). This ran...

Atrial Flutter Has Less Left Atrial Spontaneous Contrast and Higher Left Atrial Appendage Emptying Velocity Compared with Atrial Fibrillation.

The risk of stroke and thromboembolism in atrial fibrillation is established. There are clear guidelines in anticoagulation management of patient's with atrial fibrillation, however, the evidence surr...

Biomarkers determining prognosis of atrial fibrillation ablation.

Catheter ablation for rhythm control is recommended in specific patient populations with paroxysmal, persistent, or long-standing persistent atrial fibrillation. Pulmonary vein isolation is the corner...

WITHDRAWN: Pharmacological cardioversion for atrial fibrillation and flutter.

Atrial fibrillation is the commonest cardiac dysrhythmia. It is associated with significant morbidity and mortality. There are two approaches to the management of atrial fibrillation: controlling the ...

Medical and Biotech [MESH] Definitions

Rapid, irregular atrial contractions caused by a block of electrical impulse conduction in the right atrium and a reentrant wave front traveling up the inter-atrial septum and down the right atrial free wall or vice versa. Unlike ATRIAL FIBRILLATION which is caused by abnormal impulse generation, typical atrial flutter is caused by abnormal impulse conduction. As in atrial fibrillation, patients with atrial flutter cannot effectively pump blood into the lower chambers of the heart (HEART VENTRICLES).

Long-term changes in the electrophysiological parameters and/or anatomical structures of the HEART ATRIA that result from prolonged changes in atrial rate, often associated with ATRIAL FIBRILLATION or long periods of intense EXERCISE.

A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)

A THROMBIN inhibitor which acts by binding and blocking thrombogenic activity and the prevention of thrombus formation. It is used to reduce the risk of stroke and systemic EMBOLISM in patients with nonvalvular atrial fibrillation.

A morpholine and thiophene derivative that functions as a FACTOR XA INHIBITOR and is used in the treatment and prevention of DEEP-VEIN THROMBOSIS and PULMONARY EMBOLISM. It is also used for the prevention of STROKE and systemic embolization in patients with non-valvular ATRIAL FIBRILLATION, and for the prevention of atherothrombotic events in patients after an ACUTE CORONARY SYNDROME.

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