Warfarin vs Aspirin in Reduced Cardiac Ejection Fraction (WARCEF)

Objectives: Warfarin has proven effective in patients with ischemic heart disease, especially in the reduction of stroke, death, and re-infarction following myocardial infarction, and in the reduction of stroke in atrial fibrillation. Warfarin is the most promising unstudied intervention in patients with cardiac failure. This randomized, double-blind, multi-center study will define optimal antithrombotic therapy for patients with cardiac failure and patients with low ejection fraction.

The study will determine which of two commonly used treatments, Warfarin, an anticoagulant, or aspirin, a drug which affects platelet function, is better for preventing death and stroke in patients with low ejection fraction.
Sponsor: NINDS
Contact: Shunischi Homma, MD, principal investigator, associate chief, Division of Cardiology, Columbia University
Status: Currently recruiting participants

Niacin Plus Statin to Prevent Vascular Events Observational Study of Cholesterol in Coronary Arteries

Objective: The trial is designed to test whether the drug combination of extended release niacin plus simvastatin is superior to simvastatin alone, at comparable levels of on-treatment LDL-C, for delaying the time to a first major CV disease outcome over a four-year median follow-up in patients with atherogenic dyslipidemia. Prior clinical trials have found only 25 to 35% CV risk reduction using statin monotherapy. This study is needed to confirm whether statin-niacin combination therapy, designed to target a wider spectrum of dyslipidemic factors in addition to LDL-C, will provide a more substantial (greater than 50%) reduction of CV events.
Sponsor: NHLBI
Contact: Ruth McBride, study director, Axio Research Corporation, ruthm@axioresearch.com
Status: Currently recruiting participants

Investigation of the Biomarker Copeptin in Patients with Acute Myocardial Infarction

Objective: In patients with symptoms suggestive of acute coronary syndrome such as chest pain or pressure, shortness of breath, diaphoresis, and nausea, detection of a rise and/or fall of troponin with at least one value above the 99th percentile of the upper reference limit is essential to the diagnosis of acute myocardial infarction. However, current troponin testing has limitations, including antibody specificity, assay imprecision, lack of standardization, and a relatively late increase in the circulating troponin level after the onset of ischemia. Studies have shown a low diagnostic sensitivity of troponins when measured early (<6 hours) after symptom onset. Although there are some more sensitive troponin assays with a coefficient of variation 10% at the 99th percentile of a normal reference population, most troponin assays have an imprecision CV of around 20% at the 99th percentile of the reference population. The early insensitivity of troponin results in an unmet need in the clinical evaluation of patients presenting with suspected ACS and AMI.
Sponsor: Brahms AG
Contact: Alan Maisel, MD, principal investigator, San Diego VAMC
Status: Currently recruiting participants