What is the AIM-HIGH process?

What is the AIM-HIGH process?

• All scheduled visits and tests related to AIM-HIGH during the five-year cholesterol management program (lab work and ECGs) are provided at no cost to either you or your insurance company. There are also no charges for any of the scheduled AIM-HIGH visits or procedures. All patients in AIM-HIGH will be treated with a statin for the duration of the study. This, along with other study drugs, will be provided at no cost to you.

What happens during the doctor’s visits during the five-year AIM-HIGH program?

• You will participate in the study for three-five years. During the first six months, you will visit the AIM-HIGH clinic every month. After the first six months, you will need to come to the AIM-HIGH clinic about every six months.

Starting Study Medication

• If you are currently taking a “statin” drug you will continue it; however, all other cholesterol-lowering medicines must be stopped for at least four weeks before enrolling in the study.
  
• You will begin the study by taking a low dose (500 mg) of extended-release niacin and one pill of Zocor. You will increase the dose of extended-release niacin each week to a maximum of 2,000 mg a day, usually taken at bedtime. Our goal is to lower the bad cholesterol to levels advised by the National Cholesterol Education Panel (http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3xsum.pdf). The dose of Zocor (simvastatin) may be changed during the study to make sure that this goal is met.

Long Term Drug Treatment and Follow-up

• At the end of the first stage, you will continue the simvastatin and will be randomly assigned to continue on extended-release niacin or to start taking a placebo tablet. Both the placebo and the extended-release niacin tablets look identical.
  
• Because this study is “double-blinded,” neither you nor your doctor will know if you are taking extended-release niacin or placebo until the end of the study.
  
• Although both simvastatin and extended-release niacin are available by prescription at your pharmacy, you should never share these medicines with your family or friends or use them to replace other prescriptions that you might be taking.

What Happens In Between Physician Visits?

• In between clinic visits, members of the AIM-HIGH staff will phone you to see how you are doing and to check on whether you are having any problems with the medications.
  
• The clinicians at the AIM-HIGH center will have check-ups with you once a month for the first three months. After six months you’ll only visit with the AIM-HIGH staff every six months until the end of the five-year cholesterol management program.
  
• The AIM-HIGH staff will also call you after each visit to answer any questions and to see how you are doing with your medications.

What will happen during the AIM-HIGH visits?

1. You will be asked if you have had any health problems, changes in medication or hospital stays since the last visit.
2. We will check to see that you have been taking the study drugs as asked.
3. You will be given a new supply of study medication.
4. Once a year, you will have your heart rhythm recorded. This is known as an ECG.
5. At some visits, we may take a blood sample to make sure that the protein levels in your liver are normal, and to check your cholesterol levels.

Contact your AIM-HIGH doctor or nurse coordinator IMMEDIATELY if:

1. You feel you are having a side effect from the study medication.
2. You are hospitalized (or have to visit the emergency room) for any reason, including going in for a planned procedure.
3. A doctor advises you to stop the AIM-HIGH study medication.
4. You cannot make your scheduled AIM-HIGH study visit appointment.
5. You think you do not have enough study medication to last until the next study visit.

If you think you might be eligible speak with your doctor or .