NIH Sponsored Projects

Industry Sponsored Trial Experience

Atherothrombosis Interventions in Metabolic Syndrome with Low HDL/High Triglyceride and Impact on Global Health Outcomes (AIM HIGH)

AIM HIGH is a 6-year, multi-center, randomized, controlled clinical trial sponsored by the National Heart, Lung, and Blood Institute with additional funding from Kos Pharmaceuticals. The primary objective of the study is to compare the efficacy and safety of statin monotherapy (simvastatin) versus a combination therapy (statin with extended-release niacin) in reducing the risk for a composite primary endpoint of coronary heart disease death or nonfatal myocardial infarction or nonfatal stroke or hospitalization for high-risk acute coronary syndrome. The study will enroll 3,300 participants at approximately 65 clinical sites located in the US and Canada. Axio Research serves as the Coordinating Center for this trial, providing statistical, data management support, clinical coordination and project management.

Northwest Practice Based Research Collaborative in Evidence-based Dentistry (NW-PRECEDENT)

NW-PRECEDENT is one of three practice-based networks sponsored by the National Institute of Dental and Craniofacial Research. NW-PRECEDENT has enlisted over 100 practicing dentists in the Northwest to participate in a range of studies in dentistry relevant to their practice. Axio Research provides data management and Web support for this network.

Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)

The AFFIRM study, sponsored by the National Heart, Lung, and Blood Institute examined survival of patients with a Atrial fibrillation. 4060 patients were randomly assigned to one of two treatment strategies for managing this arrhythmia. The AFFIRM study was conducted in 213 clinical sites in the US and Canada. Axio provided the following services: data management, designing and analyzing the trial, preparing final reports, monitoring clinical site performance and Event Adjudication Committee coordination. Main study results were presented at ACC in March 2002 and the main paper was published in the New England Journal of Medicine in December 2002.

Azithromycin and Coronary Events Study (ACES)

ACES was a research study involving 4,000 participants from more than 25 university medical and research care centers nationwide. The purpose was to determine whether the antibiotic azithromycin decreased the heart attack risk in people with blockages in the arteries that lead to the heart. Axio provided the following services: coordinating center for the investigative sites; reviewing study protocol and informed consent forms; developing CRFs and study documentation (Manual of Operations, patient manual & brochure, and quarterly newsletters); assisting in training sessions (meeting planning and travel coordination), monitoring clinical investigator compliance; designing and implementing a electronic data capture system; monitoring enrollment and data quality; monitoring drug distribution at each site; developing and maintaining data cleaning systems; coordinating events adjudication; providing data analysis; and writing interim and final reports and publications.

Other NIH Sponsored Projects:

• Arterial Disease Multiple Intervention Trial (ADMIT) - 300 participants
• Stroke Prevention in Atrial Fibrillation (SPAF) - 4000 participants