Prolonged Enoxaparin in Primary Percutaneous Coronary Intervention

NCT03568838 | Completed Phase 4 DMC

• 1 other identifier: STH19902
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

• Recruitment Rate

  Recruitment rate over the study period

  Through study completion, average 1 year

• 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

  Through study completion, average 1 year

Secondary Outcomes (4)

• Acute stent thrombosis rate in each treatment arm

  Through study completion, average 1 year

• Rates of ST-segment resolution in each treatment arm

  Through study completion, average 1 year

• Rates of the composite outcomes

  Through study completion, average 1 year

• 1-year mortality rates

  Through study completion, average 1 year

Study Arms (2)

Enoxaparin

EXPERIMENTAL

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

Drug: Enoxaparin

Standard Therapy

NO INTERVENTION

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.

Interventions

Enoxaparin DRUG

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.

Enoxaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Medical Research Council: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29874689 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Robert Storey

  Sheffield Teaching Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 26, 2018
• Study Start: June 28, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

GB (1)