Sample Letter to Participants
Dear participant in the “AIM-HIGH” Trial,
We are writing you as a valued participant in the AIM-HIGH study to share important news before an announcement is made to the general public and news media on Thursday, May 26, 2011.
We are stopping the AIM-HIGH trial because there is little to no chance that the trial will ever show a benefit of extended release niacin in patients similar to you.
Why is AIM-HIGH being stopped?
The goal of the AIM-HIGH trial was to learn whether raising HDL (“good”) cholesterol with extended release niacin decreases the risk of heart attack, stroke, and other heart-related complications to a greater extent than with statins alone. We are stopping the AIM-HIGH trial early because we found no evidence that adding extended release niacin prevents these complications, even though it was effective at raising HDL cholesterol. The number of participants who experienced serious heart and vascular events was about the same in people who received extended release niacin as in those who received an inactive pill (placebo) instead.
Although more participants on extended release niacin experienced strokes than did those on placebo, the risk of a stroke among trial participants in either of the two groups was small - less than 1 percent per year. The apparent increase in the risk of stroke has not been seen in previous niacin studies; investigators are now analyzing the data. In summary, because we concluded that extended-release niacin provided no benefit, and because of possible safety concerns, the study was stopped 18 months earlier than planned.
Who decided to stop AIM-HIGH?
The study’s Data and Safety Monitoring Board, an independent group that monitors study progress and safety of study participants, recommended ending the trial, and the National Heart, Lung, and Blood Institute agreed and stopped the study.
What does this mean for you?
First, please stop taking your study medication from the bottle labeled “AIM-HIGH Blinded Study Drug: Extended Release Niacin or Placebo.” Please keep all the bottles, and bring them with you to your end-of-study visit, which will be scheduled soon.
Second, if you are currently taking Zocor (simvastatin) or Zetia (ezetimibe), please continue taking these drugs as directed.
Shortly after the public announcement, someone from your clinical site will contact you to schedule your end-of-study visit and answer any questions that you might have. We will continue to keep you informed of information as it becomes available in the future.
In the meantime, we request that you keep this information confidential until 11:00 a.m. Eastern time on Thursday, May 26, 2011. At that time, more information, including questions and answers, will be available on the AIM-HIGH website: http://www.aimhighheart.com/.
The AIM-HIGH investigators, sponsors and your local clinic staff would like to thank you for your dedication to and participation in this critically important study. You have helped us answer important questions about the treatment of patients with cardiovascular disease. We cannot answer important questions without your participation.
Please contact your study coordinator with any questions or concerns.
[Signed by the Study Physician and the Study Coordinator]