ACCORD is an international randomized clinical trial to develop
treatment strategies to reduce cardiovascular complications of type 2 diabetes
mellitus. ACCORD will evaluate medical
treatment strategies to control blood sugar, blood pressure, and blood
cholesterol. Hopefully, these
strategies will substantially prevent or delay cardiovascular events that
threaten patients with diabetes mellitus: heart attack, stroke, and other
vascular diseases. Ultimately, ACCORD
plans to recruit 10,000 patients and follow them up to eight years.
ACCORD is sponsored by the National Institutes of
Health. (National Heart, Lung, and
Blood Institute, National Institute of Diabetes and Digestive Diseases, and the
Eye Institute) and the Centers for Disease Control. ACCORD is comprised of 7 regional networks. The 7 network hubs coordinate
more than 60 clinical centers in the United States and Canada. The Northeastern Network Hub is on the
Columbia University Health Sciences campus and its 8 clinical centers are
located in the New York Metropolitan area and New Jersey.
To evaluate the complex protocol, a Vanguard Phase preceded
the main trial of ACCORD. Essentially,
the Vanguard Phase planned to recruit 1,000 patients and evaluate treatment
strategies to hit stringent targets for blood glucose and blood pressure. The
Northeastern Network recruitment goal for the Vanguard Phase was 120
patients. After two years of planning,
ACCORD began recruiting for the Vanguard Phase on 1/10/01. On 1/11/01, the Northeastern Network
recruited the first two patients in ACCORD.
Also, the Northeastern Network was the first ACCORD network to reach its
Vanguard recruitment goal. On 6/01/01,
Vanguard recruitment stopped after 1184 patients were randomized in the United
States and Canada. The Northeastern
Network recruited 170 patients, which represents 142% of its Vanguard
goal. The effectiveness and safety of
strategies to control blood glucose and blood pressure will be evaluated
through February 2002. The protocol
will be reviewed in the light of Vanguard Phase findings and, possibly, adjusted.
On 5/01/02, recruitment will resume and another 9,000
participants will be recruited over a 29-month period and followed until
9/30/08.
For further information, go to http://www.accord-ne.org/ and
click on FOR PATIENTS.