Prolonged Enoxaparin in Primary Percutaneous Coronary Intervention (PENNYWISE)

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S5 7AU
        • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18
  • Confirmation of the diagnosis of STEMI by the clinical team on the basis of history and ECG changes
  • Intention to proceed with PPCI
  • Treated with opiates for analgesia
  • Feasibility to obtain informed verbal consent pre PPCI

Exclusion Criteria:

  • Active bleeding that cannot be controlled by local measures
  • Pregnant patients
  • Patients with end-stage renal failure requiring renal replacement therapy
  • Patients with cardiogenetic shock
  • Known thrombocytopenia (Platelet count <100,000)
  • Known history of intracranial haemorrhage
  • Known current treatment with oral anticoagulants
  • Known history of major surgery or trauma or history of GI/GU haemorrhage within the last month
  • Known intracranial malignancy or aneurysm
  • Known allergy to enoxaparin
  • known hypersensitivity to benzylalcohol
  • Patients with known acute bacterial endocarditis
  • Known active gastric or duodenal ulceration
  • Inability to easily understand verbal information given in English for any reason
  • Inability to give informed consent due to either temporary or permanent mental incapacity
  • Current participation, or participation within the last month, in an interventional clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enoxaparin
Patients allocated to the experimental arm will receive a parenteral (IA/IV) bolus dose of 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.
No Intervention: Standard Therapy
Patients randomised to the standard therapy arm will receive treatment as guided by the treating cardiologist in line with the local standard-of-care, usually consisting of UFH and a GPI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: Through study completion, average 1 year
Recruitment rate over the study period
Through study completion, average 1 year
Bleeding rates within 24 hours
Time Frame: Through study completion, average 1 year
These rates will be compared between the two treatment groups. Trivial bleeding related to access site will be excluded. Details on bleeding events will be collected and subsequently classified according to BARC types 2-5
Through study completion, average 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute stent thrombosis rate in each treatment arm
Time Frame: Through study completion, average 1 year
Acute stent thrombosis rate in each treatment arm (within 24 hours). These rates will be compared between the two treatment groups.
Through study completion, average 1 year
Rates of ST-segment resolution in each treatment arm
Time Frame: Through study completion, average 1 year
Comparison will be undertaken between presentation ECG and ECG performed 1 hour post PPCI. We will compare rates of ST segment resolution between the two treatment groups.
Through study completion, average 1 year
Rates of the composite outcomes
Time Frame: Through study completion, average 1 year
Rates of the composite outcome of recurrent myocardial infarction, ischaemic stroke or cardiovascular death within 30 days of STEMI. These rates will be compared between the two treatment groups.
Through study completion, average 1 year
1-year mortality rates
Time Frame: Through study completion, average 1 year
These will be compared between the two groups.
Through study completion, average 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Robert Storey, Sheffield Teaching Hospitals NHS FT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2018

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

May 29, 2018

First Submitted That Met QC Criteria

June 13, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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