PENNYWISE Feasibility Trial
Research type
Research Study
Full title
Prolonged ENoxapariN in primarY percutaneous coronary intervention compared WIth Standard-of-carE therapy: Feasibility study (PENNYWISE Feasibility)
IRAS ID
233888
Contact name
Robert Storey
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Eudract number
2018-000774-30
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Heart attacks are caused by a clot blocking one of the heart arteries. When complete blockage of one of the arteries occurs, emergency treatment to unblock the affected artery and rescue the heart muscle at risk is essential. This is usually achieved by performing an emergency procedure called primary percutaneous coronary intervention (PPCI). Anticlotting treatment is also necessary to reduce the chances of further clots. As part of standard care, tablets that target small cells called platelets are given as soon as an acute heart attack is
suspected. These tablets include aspirin and ticagrelor/prasugrel. Although both ticagrelor and prasugrel are effective, their absorption can be delayed when given in combination with morphine to patients presenting with acute heart attacks. This delays onset of action and can increase the risk of further heart attacks.
Other recommended anticlotting treatments include a bolus dose of unfractionated heparin (UFH) or enoxaparin to be given at the start of the PPCI procedure. Tirofiban is occasionally used at the discretion of the treating cardiologist, to prevent or deal with thrombotic complications.
The effects of a bolus dose UFH or enoxaparin do not last long enough to bridge treatment with tablet therapy.
We have recently studied a novel regimen of enoxaparin consisting of a bolus dose, followed by a 3-6 hr infusion and found it to provide consistent anticlotting effects throughout the infusion. This is a follow-up feasibility randomised controlled study to compare the novel enoxaparin-based regimen to the local standard of care which usually consists of a bolus dose UFH ± tirofiban.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
18/YH/0108
Date of REC Opinion
3 Jun 2018
REC opinion
Further Information Favourable Opinion