Prolonged ENoxapariN in primarY Percutaneous Coronary Intervention; a Pilot Pharmacodynamic study (PENNY PCI study)

Phase 1

• Conditions: ST elevation myocardial infarction.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-000485-29-GB
• Lead Sponsor: Dr

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-20
• Study Completion: 2018-03-30
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

1.Age = 18
2.Confirmation of the diagnosis of STEMI by the clinical team on the basis of history, ECG changes and angiographic findings
3.Pre-treatment with either ticagrelor or prasugrel
4.Intention to proceed with PPCI
5.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 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Active bleeding that cannot be controlled by local measures
2.Female patients of child bearing age who have not had a sterilisation procedure
3.Patients with end stage renal failure requiring renal replacement therapy
4.Known thrombocytopenia (Platelet count < 100,000/µL)
5.Known history of intracranial haemorrhage
6.Known current treatment with oral anticoagulants
7.Known history of major surgery or trauma or history of GI/GU haemorrhage within the last month
8.Known intracranial malignancy or aneurysm
9.Known allergy to enoxaparin
10.Inability to easily understand verbal information given in English for any reason
11. Inability to give informed consent due to either temporary or permanent mental incapacity

Study & Design

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