Myocardial Infarction Clinical Trial
— PENNYWISEOfficial title:
Prolonged Enoxaparin in Primary Percutaneous Coronary Intervention Compared With Standard of Care Therapy - The PENNYWISE Feasibility Study
NCT number | NCT03568838 |
Other study ID # | STH19902 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 28, 2018 |
Est. completion date | May 1, 2020 |
Verified date | November 2022 |
Source | Sheffield Teaching Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 1, 2020 |
Est. primary completion date | May 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | South Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Sheffield Teaching Hospitals NHS Foundation Trust | Medical Research Council |
United Kingdom,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment Rate | Recruitment rate over the study period | Through study completion, average 1 year | |
Primary | 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 | 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. | Through study completion, average 1 year | |
Secondary | 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. | Through study completion, average 1 year | |
Secondary | 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. | Through study completion, average 1 year | |
Secondary | 1-year mortality rates | These will be compared between the two groups. | Through study completion, average 1 year |
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