Prolonged ENoxapariN in primarY percutaneous coronary intervention compared WIth Standard-of-carE therapy: Feasibility study (PENNYWISE Feasibility)

Phase 1

• Conditions: ST-elevation myocardial infarction; MedDRA version: 20.0Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders

• Registration Number: EUCTR2018-000774-30-GB
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-30
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified