A Pharmacodynamic Evaluation of Switching from Ticagrelor to Prasugrel

• Research type

  Research Study

• Full title

  A Pharmacodynamic Evaluation of Switching from Ticagrelor to Prasugrel in Subjects with Stable Coronary Artery Disease: 2nd Switching Antiplatelet Agents

• IRAS ID

  92718

• Contact name

  Nicholas Curzen

• Sponsor organisation

  Daiichi Sankyo Inc.

• Eudract number

  2011-004064-29

• ISRCTN Number

  n/a

• Research summary

  The purpose of the study is to examine the effect of switching study drugs on a patient??s platelets. Platelets are very small cell particles, circulating in the blood, which are essential to help form clots and so stop any bleeding. If clots form within a hardened blood vessel such as an artery they can be very dangerous as they can cut off the blood supply, causing a heart attack, stroke or death. The drugs being investigated inhibit the clumping of platelets and so reduce the chance of a blood clot forming. Prasugrel is licensed for use in patients who have had a heart attack or unstable angina, and have been treated with a procedure to open the blocked arteries in the heart. Ticagrelor is licensed for use in patients who have had a heart attack or unstable angina. Both drugs act reduce the risk of a heart attack, stroke or death from coronary disease. This is a Phase 4, multicentre, open label, randomized, 3arm, parallel design study of subjects with stable coronary artery disease. The study will be conducted in several study sites, in the UK, Germany and the US; both the subject and study doctor will know what treatment the subject is receiving and treatment allocation will be done by chance. There are two study drugs; Ticagrelor is licensed, the Prasugrel being used in this study is unlicensed - it is a modified version of the licensed Prasugrel (Efient). Efient and Ticagrelor are licensed for use in the UK, for patients who have had an ACS and have been treated with PCI. The modified Prasugrel contains exactly the same active ingredients, with two extra excipients added, in an attempt to increase the product??s shelf life. This study will compare the pharmacodynamic effect of prasugrel 10mg taken once daily (QD), with ticagrelor 90mg taken twice daily (BID). Subjects will be randomized in a 1:1:1 ratio to one of the following treatment arms: ?½ A - Prasugrel 60mg LD, followed by prasugrel 10mg MD QD ?½ B - Prasugrel 10mg MD QD ?½ C - Ticagrelor 90mg MD BID Subjects choosing to take part will undergo two weeks of screening procedures and if suitable will then receive the study treatment for up to 15 days. There will be six visits overall, and a follow-up call two weeks later.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  12/SC/0318

• Date of REC Opinion

  11 Jun 2012

• REC opinion

  Favourable Opinion