Prolonged Enoxaparin in Primary Percutaneous Coronary Intervention

• Status: Completed
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborator: Medical Research Council
• Treatments: Enoxaparin

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.