FRACTAL

• Research type

  Research Study

• Full title

  A phase IIa, randomized, 2-arm parallel-group, placebo-controlled, double-blind, multi-centre trial to evaluate safety, tolerability, anti-inflammatory and cardio- protective effects after intravenous and oral administration of KAND567 in ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention

• IRAS ID

  1003810

• Contact name

  Ioakim Spyridopolous

• Contact email

  ioakim.spyridopoulos@ncl.ac.uk

• Sponsor organisation

  Newcastle upon Tyne Hospitals NHS Foundation Trust

• Eudract number

  2021-001354-53

• ISRCTN Number

  ISRCTN18402242

• Research summary

  Coronary heart disease is a condition in which the supply of blood and oxygen to the heart is reduced due to the narrowing of the arteries (blood vessels) supplying the heart. A heart attack is caused when one of the arteries becomes blocked. Modern treatment for heart attacks involves opening the blocked artery with a balloon and placing a stent (a small metal scaffold) in the artery to hold it open. This treatment is called primary percutaneous coronary intervention (PPCI).
  Recently, research has shown that after opening the artery, inflammation develops within the heart. This inflammation is generated by the immune system. Our initial studies have suggested that certain immune system cells (T­ cells) that express the chemokine receptor CX3CR1 may be involved in causing much of the damage that occurs in the heart following a heart attack. The drug KAND567 inhibits CX3CR1, and thus temporarily inhibits the immune system.

  The aim of this study is to investigate whether KAND567 can be safely used in patients with an acute heart attack, and whether KAND567 inhibits the adverse reaction of the immune system that causes hyperinflammation.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  21/NW/0178

• Date of REC Opinion

  13 Jul 2021

• REC opinion

  Further Information Favourable Opinion