A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome
Summary
This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Coronary Heart Disease
Intervention
dalcetrapib, Placebo, Evidence-based medical care for Acute Coronary Syndrome
Location
Birmingham
Alabama
United States
35235
Status
Recruiting
Source
Hoffmann-La Roche
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00658515
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Evidence-based Medicine
An approach of practicing medicine with the goal to improve and evaluate patient care. It requires the judicious integration of best research evidence with the patient's values to make decisions about medical care. This method is to help physicians make proper diagnosis, devise best testing plan, choose best treatment and methods of disease prevention, as well as develop guidelines for large groups of patients with the same disease. (from JAMA 296 (9), 2006)
Evidence-based Dentistry
An approach or process of practicing oral health care that requires the judicious integration of systematic assessments of clinical relevant scientific evidence, relating to the patient's oral and medical condition and history, with the dentist's clinical expertise and the patient's treatment needs and preferences. (from J Am Dent Assoc 134: 689, 2003)
Coronary Care Units
The hospital unit in which patients with acute cardiac disorders receive intensive care.
Evidence-based Nursing
A way of providing nursing care that is guided by the integration of the best available scientific knowledge with nursing expertise. This approach requires nurses to critically assess relevant scientific data or research evidence, and to implement high-quality interventions for their nursing practice.
Subacute Care
Medical and skilled nursing services provided to patients who are not in an acute phase of an illness but who require a level of care higher than that provided in a long-term care setting. (JCAHO, Lexikon, 1994)
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PubMed Articles
Effects of Dalcetrapib in Patients with a Recent Acute Coronary Syndrome.
Background In observational analyses, higher levels of high-density lipoprotein (HDL) cholesterol have been associated with a lower risk of coronary heart disease events. However, whether raising HDL...
Abstract Objective: Dalcetrapib increases high-density lipoprotein cholesterol (HDL-C) levels through effects on cholesteryl ester transfer protein (CETP). As part of the dalcetrapib dal-HEART clinica...
No clinically relevant drug-drug interactions when dalcetrapib is co-administered with atorvastatin.
Objectives: Dalcetrapib, which targets cholesteryl ester transfer protein, is in clinical development for prevention of cardiovascular events and is likely to be used concomitantly with statins. Two s...
Objective: To assess the effect of the UGT inhibitor probenecid on the pharmacokinetics of dalcetrapib, an investigational drug whose pharmacologically active thiol form undergoes glucuronidation (fm...
Rivaroxaban in Patients with a Recent Acute Coronary Syndrome.
Background Acute coronary syndromes arise from coronary atherosclerosis with superimposed thrombosis. Since factor Xa plays a central role in thrombosis, the inhibition of factor Xa with low-dose ri...
