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Randomised clinical trial of Bococizumab in subjects with hyperlipidemia or mixed dyslipidemia at risk of cardiovascular events.

The SPIRE program includes several different clinical studies of an investigational drug being studied in people with high cholesterol and risk factors for heart disease. Each study is evaluating different groups of people who still have high cholesterol despite being treated with cholesterol medication.

Background

SPIRE program studies are designed to answer the following questions:

  • What is the effect of the study drug, Bococizumab, on low-density lipoprotein (LDL) cholesterol in people who still have high cholesterol, despite taking their current cholesterol lowering medicine?
  • What is the effect of the drug on the risk of heart attack or stroke?
  • SPIRE 1 and SPIRE 2 trials: To compare the effect of Bococizumab versus placebo on reducing the occurrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularisation, at 5 years

To be eligible, participants must be aged 18 years or older. You must have a medical history of or be at risk for problems like heart attack, stroke, diabetes or poor blood circulation in your arms, legs, feet or hands.


Study Design: RCT
Sponsor:  Pfizer, University of Oxford (leading GP practice recruitment across the UK.)
Chief Investigator: Professor Richard Hobbs, University of Oxford
Ethical Approval:  EudraCT Number: 2013-002795-41, 2013-002646-36