AMG 145 and Statin Therapy in patients with Cardiovascular Disease

• Research type

  Research Study

• Full title

  A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When AMG 145 is Used in Combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease

• IRAS ID

  108069

• Contact name

  Derek Connolly

• Eudract number

  2012-001398-97

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Cardiovascular disease is a leading cause of death in developed countries. Cardiovascular disease is commonly linked with having high cholesterol levels in the blood stream. By lowering cholesterol levels, the risk of problems that occur in cardiovascular disease such as heart attacks and strokes is also reduced. A common method to lower cholesterol levels is to use medication such as statins. AMG 145 is a new experimental drug that works differently to statins and other cholesterol-lowering medications and may lower cholesterol levels. The purpose of this study is to determine whether AMG 145 when used with statins can further reduce the risk in patients with a history of cardiovascular disease-related problems such as heart attacks or strokes. After signing a informed consent, patient??s lipid levels will be monitored for up to 12 weeks, when they will receive cholesterol lowering medication-all patients will also be required to take Atorvastatin at maximally tolerated dose between 20-80mg daily. If the patient??s cholesterol levels are stable and their blood tests are within the requirements for the study, they will be allowed onto the study. Patients will be randomly allocated to: 2mL AMG145/placebo every 2 weeks for 6 months, then the option of either: 2mL AMG 145/placebo every 2 weeks or 6mL AMG145/placebo every 4 weeks The study includes collecting blood samples used to test for special proteins (biomarkers) to measure the effects of AMG 145. Patients will also be invited to consent to allow their blood samples to be used for pharmacogenetic testing (testing your DNA). It is estimated that patients will be on the study for between 40 and 58 months. An external independent Data Monitoring Committee will formally review data from this and other ongoing studies with AMG 145 to ensure there is no avoidable increased risk for harm to patients.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  12/WM/0341

• Date of REC Opinion

  9 Nov 2012

• REC opinion

  Further Information Favourable Opinion