MEDI6012 in Acute ST Elevation Myocardial Infarction D5780C0007

• Research type

  Research Study

• Full title

  A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction

• IRAS ID

  242715

• Contact name

  Stephen Wheatcroft

• Contact email

  s.b.wheatcroft@leeds.ac.uk

• Sponsor organisation

  MedImmune, LLC, a wholly owned subsidiary of AstraZeneca

• Eudract number

  2017-004521-32

• Duration of Study in the UK

  2 years, 10 months, 1 days

• Research summary

  This study will test MEDI6012 in acute STEMI patients (a serious type of heart attack). Patients with acute STEMI are at risk of future major adverse cardiovascular events, including death, further heart attacks, stroke, and heart failure.
  This is a Phase 2b randomized, part blinded, placebo-controlled study to evaluate the effectiveness, safety, pharmocokinetics/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult with acute STEMI. At least 414 subjects are planned to be randomized across approximately 40 study sites in approximately 10 countries.

  Currently, the only therapy shown to reduce the size of heart muscle damage in humans with acute STEMI is primary percutaneous coronary intervention (PCI), which is a non-surgical procedure to reduce narrowing of the arteries. MEDI6012 increases HDL-C, HDL-CE, and CE. In addition, MEDI6012 increases apoA1 (a protein that has a role in lipid metabolism) after both single and multiple doses, shown to protect the heart from damage in nonclinical studies and protect from plaque formation in clinical studies. The increase in HDL-C is rapid, enabling MEDI6012 to induce HDL-C mediated cardio-protection in the acute STEMI setting.
  Clinical studies have demonstrated that single and multiple doses of MEDI6012 are generally well tolerated. Two identified risks with MEDI6012 are injection site reactions, which were observed at low frequencies when administered by IV, and anti-drug antibodies.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  18/YH/0215

• Date of REC Opinion

  2 Aug 2018

• REC opinion

  Further Information Favourable Opinion