This phase 3 trial located in the United States aims to evaluate the effectiveness of bococizumab(RN316) in reducing cardiovascular events such as a heart attack or stroke. The outcome to be examined is the occurrence of cardiovascular events.
The details
Bococizumab is a new drug being developed to treat patients at high risk of having a cardiovascular event. (including cardiovascular death, heart attack, stroke and abnormal heart rhythm). It works by targeting a protein to reduce levels of cholesterol (fats that build up in the blood vessels) in the body. It is suggested that bococizumab may help reduce the occurrence of heart attack and stroke.
Who are they looking for?
This study is recruiting 17,000 participants who are at high risk of a cardiovascular event. Participants should be receiving medication that lowers their cholesterol levels. They should have low-density lipoprotein cholesterol ("bad cholesterol") levels between 70 mg/dL and 100 mg/dL.
Participants should not be planning to have procedures such as percutaneous coronary intervention (procedure to widen narrowed arteries) or coronary artery bypass graft (diverting blood flow through a new blood vessel). Participants should not have significant kidney disease.
How will it work
Patients will be randomly assigned to 1 of 2 treatment groups.
Patients in the first treatment group will receive bococizumab every two weeks subcutaneously (injected under the skin).
Patients in the second treatment group will receive a placebo (drug that has no effect) every two weeks subcutaneously.
Patients will receive treatment for about 3 to 4 years after first starting the study and be monitored for the occurrence of cardiovascular events.
