APACS-HPR Trial

• Research type

  Research Study

• Full title

  Evaluating the benefit of additional platelet inhibition in acute coronary syndrome patients with high platelet reactivity undergoing PCI

• IRAS ID

  73199

• Sponsor organisation

  Royal Brompton & Harefield NHS Foundation Trust

• Eudract number

  2010-020219-35

• ISRCTN Number

  N/A

• Research summary

  Patients admitted to hospital with chest pain due to reduced blood flow to heart muscle (diagnosis Acute Coronary Syndrome) can be treated with medication and an angioplasty ñ stent procedure, which restores blood flow to the heart. Antiplatelet drugs (Aspirin and Clopidogrel) are blood thinning treatments and research has reported they reduce heart attacks, death and stroke. We know some patients do not respond fully to Clopidogrel but currently patients are not tested for this. We wish to perform a trial to identify those patients who do not respond fully to Clopidogrel and randomise them to either Prasugrel (newer drug) or a higher dose of Clopidogrel.Patients admitted to the hospitals (2 in the UK and 1 in Germany) will be asked for their consent to participate. A blood sample is tested for platelet activity. 1) Low platelet activity result means patient has responded well to Clopidogrel and will continue on the routine dose. They will be entered into an observational registry. Data will be collected of routine blood tests and investigations, medication and procedures. Their GP will be contacted at about 30 days to see if they are alive. 2) High platelet activity results means patient has not responded fully to Clopidogrel. These patients will be randomly allocated to a higher dose of Clopidogrel or new drug Prasugrel. Data will be collected of routine blood tests and investigations, medication and procedures. A hospital visit at 30ñ5 days is required to assess how patients are doing, medications and occurrence of any events. Research blood samples for all patients are required for platelet activity, biomarker and genetic sub-studies.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  11/EM/0071

• Date of REC Opinion

  18 Jul 2011

• REC opinion

  Further Information Favourable Opinion