Point of care platelet activity measurement in Primary Percutaneous Coronary Intervention (PPCI)

Not Applicable

Completed

• Conditions: ST elevation myocardial infarction; Circulatory System; Acute myocardial infarction

• Registration Number: ISRCTN82257414
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust (UK)

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24708700 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26672598

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-07
• Study Completion: 2012-10-31
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

A participant may enter the study if ALL of the following apply:
1. Admitted with acute ST elevation myocardial infarction (STEMI)
2. Treated with PPCI at the time of index procedure

Exclusion Criteria

A participant may not enter the study if ANY of the following apply:
1. Unable to take prasugrel
2. Unable to take bivalirudin
3. Haemodynamic instability/cardiogenic shock
4. Current treatment with clopidogrel or prasugrel

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. The platelet function assessment measured in peripheral whole blood<br> 2. Functional assessment of Adenosine diphosphate (ADP) receptor, arachidonic acid pathway, and thrombin related platelet activation will be measured using a multiple electrode analyser (MEA - Multiplate platelet function analysis)<br><br> Platelet function (measured in peripheral 'whole' blood, see above) will be assessed on arrival at hospital, at completion of the PPCI, 1, 2 and 24 hours after the completion of the PPCI. These measurements will allow the study to test how the profile of platelet function changes over the period of time in which the effect of bivalirudin wanes and prasugrel increases, by assessing the interaction between door-to-balloon time and time-after-completion of PPCI.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Incidence of adverse clinical events at 24hours and 30days, including:<br> 1. Major adverse cardiac events (MACE) - a composite of target vessel revascularisation, target lesion revascularisation, non-fatal myocardial infarction, and cardiac death<br> 2. Bleeding complications - using Thrombolysis In Myocardial Infarction (TIMI) major and minor bleeding criteria<br> 3. Stent thrombosis [Academic Research Consortium (ARC) definition]<br>