PENNY PCI Study
Research type
Research Study
Full title
Prolonged ENoxapariN in primarY Percutaneous Coronary Intervention; a Pilot Pharmacodynamic study (PENNY PCI study)
IRAS ID
221203
Contact name
Robert Storey
Contact email
Sponsor organisation
Dr
Eudract number
2017-000485-29
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
Heart attacks are caused by a clot blocking one or more of the heart arteries (coronary 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 heart attacks. As part of standard care, tablets that target small cells called platelets (central to blood clot formation) 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, the onset of action is delayed by up to 8 hours when given in the context of an acute heart attack. This delay in onset of action can increase the risk of further heart attacks.
Enoxaparin is an anticlotting treatment that targets the other aspect of clot formation known as the coagulation cascade. Enoxaparin or an alternative is recommended as a single dose to support the PPCI procedure. The effects of a single shot of enoxaparin do not last long enough to bridge the gap in anticlotting treatment caused by the delayed action of ticagrelor/prasugrel. Since we have realised the delayed onset of action of tablet therapy, we have been using another drug called tirofiban as a drip. Tirofiban blocks platelets effectively, but greatly increases the risk of bleeding events.
We believe that giving enoxaparin as a drip for 3-6 hours (following the single dose) instead of tirofiban, would be sufficient to bridge the gap in anticlotting effect without greatly increasing the risk of bleeding. This is a pilot study to assess the effects of enoxaparin drip in patients presenting with acute heart attacks and undergoing emergency treatment with PPCI.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0103
Date of REC Opinion
12 May 2017
REC opinion
Further Information Favourable Opinion