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Trial Summaries
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ACCORD MAIN TRIAL LAUNCHES
(ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES)
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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 70
clinical centers in the United States and
Canada. The Northeastern Network Hub
is on the Columbia University Health
Sciences campus and its 12 clinical centers
are located in New York 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.
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,
142% of its vanguard goal. The effectiveness and
safety of strategies to control blood glucose and
blood pressure were evaluated through February 2003.
The protocol was revised in the light of vanguard
phase findings. On 2/10/03, recruitment resumed
and another 9,000 participants will be recruited
over a 30-month period and followed until 6/30/09.
For further information, go to
http://www.accord-ne.org/
and click on FOR PATIENTS or call 212-305-6357.
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