Advertisement

Topics

VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome

2014-07-23 21:08:58 | BioPortfolio

Summary

The objective of this study is to evaluate the safety and efficacy of short-term A-002 treatment on morbidity and mortality when added to atorvastatin and standard of care in subjects with an acute coronary syndrome (ACS).

Description

A double-blind randomized parallel group placebo controlled study in subjects presenting with an ACS. Up to 6500 subjects will be randomized to receive either A-002 500 mg once daily (QD) or placebo tablets in addition to atorvastatin QD and standard of care. Treatment will be 16 weeks in duration. The dose of atorvastatin shall be adjusted after 8 weeks if subject's LDL-C is ≥100 mg/dL, but otherwise must remain stable throughout the16-week duration of study. The survival status for all enrolled subjects will be ascertained 6 months after they complete the study.

Randomization must occur within ≤96 hours of hospitalization for the index ACS event, or if already hospitalized, within ≤96 hours of index event diagnosis. Follow-up visits will occur at Hours 6, 12, 24, 48, 72, 96 and Weeks 1, 2, 4, 8, and 16.

Study Design

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

Conditions

Acute Coronary Syndrome

Intervention

A-002, varespladib methyl

Location

Investigator Site 1027
Kalispell
Montana
United States
59901

Status

Recruiting

Source

Anthera Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:58-0400

Clinical Trials [3091 Associated Clinical Trials listed on BioPortfolio]

FRANCIS-ACS Trial: A Study of the Safety and Efficacy of A 002 in Subjects With Acute Coronary Syndromes

The objective of this study is to evaluate the safety and efficacy of A 002 when added to high dose atorvastatin in subjects with an acute coronary syndrome (ACS)

Myeloperoxidase and Multi-Markers In the Diagnosis of Diagnoses of Acute Coronary Syndrome (MIDAS) - Sample Procurement

The purpose of the study is to procure blood samples from patients who present to the Emergency Department with suspected ACS (Acute Coronary Syndrome).

Jakarta Acute Coronary Syndrome Registry

Jakarta acute coronary syndrome enrolled patients with acute coronary syndrome admitted to the emergency department of a national cardiac referral hospital.

Investigation of the Heart and the Clinical Course of Acute Coronary Syndrome in Patients With Non-obstructive Lesion of the Coronary Arteries

The purpose of this study is to improve the differential diagnosis and clinical outcomes of acute coronary syndrome with non-obstructive coronary arteries, to investigate the relationship ...

RuSsian RegisTry of Acute CoronaRy SyndromE TreAtMent and Approach in Dual Antiplatelet Therapy

This NIS is a multi-centre, observational, descriptive, cross-sectional study including all consecutive patients with Acute Coronary Syndrome (ACS) and a single-arm, prospective, longitudi...

PubMed Articles [12600 Associated PubMed Articles listed on BioPortfolio]

Destructive changes in epicardial arteries and coronary microcirculation in women with non st elevation acute coronary syndrome, depending on hormonal status.

Introduction: Acute forms of cardiovascular are a major problem in the structure of morbidity and mortality, especially among perimenopausal women. The most important is nature and features of the dam...

Endocan: a biomarker predicting successful reperfusion after coronary artery by-pass surgery of acute coronary syndrome patients.

Endothelial specific molecule 1 (Endocan) is a biomarker of the inflammatory process occurring in endothelial cells. It was shown that endocan was increased in acute coronary syndromes. We aimed at in...

Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome.

Patients who have had an acute coronary syndrome are at high risk for recurrent ischemic cardiovascular events. We sought to determine whether alirocumab, a human monoclonal antibody to proprotein con...

MRI findings in patients with acute coronary syndrome and unobstructed coronary arteries.

The underlying diagnosis in patients with acute coronary syndrome (ACS) and unobstructed coronary arteries remains a diagnostic challenge. We analyzed the value of magnetic resonance imaging (MRI) in ...

Factors associated with depressive symptoms in patients with acute coronary syndrome undergoing percutaneous coronary intervention: A prospective cohort study.

To identify the association between possible factors and depression among post-percutaneous coronary intervention patients with acute coronary syndrome.

Medical and Biotech [MESH] Definitions

A piperazine derivative and PLATELET AGGREGATION INHIBITOR that is used to prevent THROMBOSIS in patients with ACUTE CORONARY SYNDROME; UNSTABLE ANGINA and MYOCARDIAL INFARCTION, as well as in those undergoing PERCUTANEOUS CORONARY INTERVENTIONS.

Abnormal balloon- or sac-like dilatation in the wall of CORONARY VESSELS. Most coronary aneurysms are due to CORONARY ATHEROSCLEROSIS, and the rest are due to inflammatory diseases, such as KAWASAKI DISEASE.

An episode of MYOCARDIAL ISCHEMIA that generally lasts longer than a transient anginal episode but that does not usually result in MYOCARDIAL INFARCTION.

A congenital coronary vessel anomaly in which the left main CORONARY ARTERY originates from the PULMONARY ARTERY instead of from AORTA. The congenital heart defect typically results in coronary artery FISTULA; LEFT-SIDED HEART FAILURE and MITRAL VALVE INSUFFICIENCY during the first months of life.

Malformations of CORONARY VESSELS, either arteries or veins. Included are anomalous origins of coronary arteries; ARTERIOVENOUS FISTULA; CORONARY ANEURYSM; MYOCARDIAL BRIDGING; and others.

More From BioPortfolio on "VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Cardiology
Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...

Acute Coronary Syndromes ACS
Acute Coronary Syndromes (ACS) is an umbrella term for situations where the blood supplied to the heart muscle is suddenly blocked. Treatment for acute coronary syndrome includes medicines and a procedure known as angioplasty, during which doctors inflat...


Searches Linking to this Trial