Platelet Function in Resuscitated Patients

Completed

• Conditions: Acute ST Segment Elevation Myocardial Infarction

• Registration Number: NCT02914795
• Lead Sponsor: Medical University of Graz

Brief Summary

Approx. 65% of resuscitated patients at the intensive care unit for internal medicine are due to myocardial infarction. Almost all patients are initially diagnosed and treated in the cath lab. Therapy usually consists of one or more stent implantations. After implantation of a coronary stent, dual platelet inhibition is necessary for 12 months. Insufficient platelet inhibition causes an pronounced increase in risk of stent thrombosis. Therefore, knowledge of the individual platelet function is valuable.

Several factors potentially promote a delayed or reduced mode of action of platelet function inhibitors in resuscitated patients:

1. oral administration is impossible and medication needs to be administered via a gastric line.

2. gastric absorption is delayed after resuscitation

3. according to current guidelines patients are treated with therapeutic hypothermia. Including the time of rewarming cooling period is \~48h

Detailed Description

Patients after successful resuscitation associated to a myocardial infarction will be included into the study the morning after the index event. Patients get dual platelet inhibition at the discretion of the interventionist. Patients are treated with therapeutic hypothermia according to the local Standard operating procedure for 24h and rewarming is performed within an additional 20h. Platelet function is measured every morning and Aspirin mediated as well as P2Y12 (purinergic G protein-coupled receptors-12)-inhibition mediated platelet function inhibition is recorded. All relevant clinical data including APACHE (Acute Physiology and Chronic Health Evaluation) and SOFA ( Sequential Organ Failure Assessment score) scores are collected.

The degree of platelet inhibition over time (7 days) and differences between the three drugs tested will be evaluated by optical aggregometry and by using the commercial VerifyNow test system.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-05-12
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-26
• Results First Submitted: 2018-03-21
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-02
• Last Update Submitted: 2020-12-02
• Results First Posted: 2020-12-03
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Myocardial infarction
• dual platelet inhibition
• resuscitation
• therapeutic hypothermia

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Platelet Inhibition Measured With Optical Aggregometry	day 3	Median (Inter-Quartile Range) Collagen AUC values on Day 3 measured with optical aggregometry The more light signal is detected, the better thrombocyte function is.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis	7 days

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria