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Prolonged Enoxaparin in Primary Percutaneous Coronary Intervention (PENNYWISE)

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Enoxaparin
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sheffield Teaching Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enoxaparin

Standard Therapy

Arm Description

Patients allocated to the experimental arm will receive a parenteral (IA/IV) bolus dose of enoxaparin.

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.

Outcomes

Primary Outcome Measures

Recruitment Rate
Recruitment rate over the study period
Bleeding rates within 24 hours
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

Secondary Outcome Measures

Acute stent thrombosis rate in each treatment arm
Acute stent thrombosis rate in each treatment arm (within 24 hours). These rates will be compared between the two treatment groups.
Rates of ST-segment resolution in each treatment arm
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.
Rates of the composite outcomes
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.
1-year mortality rates
These will be compared between the two groups.

Full Information

First Posted
May 29, 2018
Last Updated
November 10, 2022
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT03568838
Brief Title
Prolonged Enoxaparin in Primary Percutaneous Coronary Intervention
Acronym
PENNYWISE
Official Title
Prolonged Enoxaparin in Primary Percutaneous Coronary Intervention Compared With Standard of Care Therapy - The PENNYWISE Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Medical Research Council

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomised (1:1) using an opaque sealed envelope methodology prior to coronary angiography. 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. 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enoxaparin
Arm Type
Experimental
Arm Description
Patients allocated to the experimental arm will receive a parenteral (IA/IV) bolus dose of enoxaparin.
Arm Title
Standard Therapy
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
Recruitment rate over the study period
Time Frame
Through study completion, average 1 year
Title
Bleeding rates within 24 hours
Description
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
Time Frame
Through study completion, average 1 year
Secondary Outcome Measure Information:
Title
Acute stent thrombosis rate in each treatment arm
Description
Acute stent thrombosis rate in each treatment arm (within 24 hours). These rates will be compared between the two treatment groups.
Time Frame
Through study completion, average 1 year
Title
Rates of ST-segment resolution in each treatment arm
Description
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.
Time Frame
Through study completion, average 1 year
Title
Rates of the composite outcomes
Description
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.
Time Frame
Through study completion, average 1 year
Title
1-year mortality rates
Description
These will be compared between the two groups.
Time Frame
Through study completion, average 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Storey
Organizational Affiliation
Sheffield Teaching Hospitals NHS FT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S5 7AU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29874689
Citation
Sumaya W, Parker WAE, Fretwell R, Hall IR, Barmby DS, Richardson JD, Iqbal J, Adam Z, Morgan KP, Gunn JP, Mason AE, Judge HM, Gale CP, Ajjan RA, Storey RF. Pharmacodynamic Effects of a 6-Hour Regimen of Enoxaparin in Patients Undergoing Primary Percutaneous Coronary Intervention (PENNY PCI Study). Thromb Haemost. 2018 Jul;118(7):1250-1256. doi: 10.1055/s-0038-1657768. Epub 2018 Jun 6.
Results Reference
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Prolonged Enoxaparin in Primary Percutaneous Coronary Intervention

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