NCT03568838

Prolonged Enoxaparin in Primary Percutaneous Coronary Intervention

Prolonged Enoxaparin in Primary Percutaneous Coronary Intervention Compared With Standard of Care Therapy - The PENNYWISE Feasibility Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a feasibility study aiming to generate pilot data on safety and efficacy of a novel anticoagulant regimen (enoxaparin bolus and prolonged infusion) compared to the local standard-of-care in opiate-treated patients undergoing primary percutaneous coronary intervention.

Detailed description

Delayed absorption of oral P2Y12 inhibitors in patients undergoing primary percutaneous coronary intervention (PPCI) may increase the risk of stent thrombosis. Parenteral treatment is needed mitigate this risk. We have recently shown a novel regimen of enoxaparin (bolus 0.75 mg/kg followed by an infusion of 0.75 mg/kg/6h) to provide consistent antithrombotic effects until the end of the infusion (1). We have also demonstrated the high prevalence of delayed platelet inhibition in opiate-treated patients (1). This is a feasibility study for a larger randomised controlled trial (RCT). We aim to assess recruitment rate and collect pilot data on safety and efficacy. This will be a single-centre, open-label RCT comparing this novel regimen of enoxaparin to the local standard-of-care which usually consists of unfractionated heparin and a glycoprotein IIb/IIIa inhibitor. The study population will be opiate-treated patients undergoing PPCI. Pre PPCI, patients will be allocated in 1:1 ratio using a simple randomisation method using sealed envelopes, to either enoxaparin 0.75 mg/kg bolus followed by 0.75 mg/kg infusion over 6 hours (n=50) or the standard-of-care of UFH and tirofiban (n=50).

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Enoxaparin	Patients allocated to the experimental arm will receive a parenteral (IA/IV) bolus dose of enoxaparin (0.75 mg/kg) pre PPCI followed by an infusion of 0.75 mg/kg over a 6-hour period to be started as soon as possible when PPCI starts.

Timeline

• Start date: 2018-06-28
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2018-06-26
• Last updated: 2022-11-15

Locations

1 site across 1 country: United Kingdom