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The Office of Clinical Trials

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Clinical Trial News
Winter 2000-2001

Clinical Trial News
Winter 1999-2000


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The Clinical Trials Network

ACCORD VANGUARD RECRUITMENT ENDS
(ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES)


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.

 

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