This phase 3 trial will determine if bempedoic acid (BPDA) reduces the risk of cardiovascular events (CVEs) in statin-intolerant (ST-IT) patients. The main outcome will be the time taken for a CVE to occur.
The details
Cardiovascular disease (CVD) is a serious condition that can lead to serious events (CVEs). CVEs include heart attacks, strokes, and death. To prevent CVEs, patients may take medications. Statins are a type of medication commonly used in patients with CVD. Statins prevent the production of cholesterol. Cholesterol can build up in the arteries. This forms plaques in the arteries leading to blockages. Some patients do not respond well to statins. Other patients may not be able to take statins due to side effects. These patients are called statin-intolerant (ST-IT).Bempedoic acid (BPDA) is a new drug to reduce cholesterol levels.
This trial will determine if BPDA reduces the risk of CVEs in ST-IT patients. The main outcome will be the time taken for a CVE to occur.
Who are they looking for?
This study will recruit approximately 12,600 patients with diagnosed CVD or at a high risk of CVD. Patients must have a reported history of statin intolerance.
Patients cannot take part in the trial if they have had a recent major CVE. These include mild stroke (transient ischemic attack, TIA) or arrhythmia (irregular heartbeat). Patients with a history of severe heart failure and uncontrolled hypertension or diabetes will be excluded. Patients also cannot participate if they have blood triglyceride (fat) levels higher than 500 mg/dL.
How will it work
Patients will be randomly assigned to receive either BPDA or placebo. A tablet of 180 mg BPDA (or placebo) will be taken once daily. The study will last on average 3.75 years. CVEs will be recorded.
The main outcome will be the time taken for a CVE to occur.
