Platelet Function in Resuscitated Patients-2

Completed

• Conditions: Cardiac Arrest; Acute Myocardial Infarction
• Interventions: Diagnostic Test: diagnostic test of platelet function

• Registration Number: NCT03445546
• 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, secured inhibition and knowledge of the individual platelet function is valuable.

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 using cangrelor as P2Y12 (purinergic G protein-coupled receptors-12) inhibitor plus acetylsalicylic acid (ASS). Patients are treated with therapeutic hypothermia according to the local Standard operating procedure for 24h and rewarming is performed within an additional 5 to 20h. Platelet function is measured every morning and ASS mediated as well as P2Y12 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 (4 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: 2016-05-01
• Study First Submitted: 2018-02-16
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-26
• Primary Completion: 2018-05-15
• Study Completion: 2018-05-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intravenous P2Y12 inhibition	diagnostic test of platelet function	Patients with cardiac arrest and myocardial infarction treated with intravenous P2Y12 Inhibitor (cangrelor)
oral P2Y12 inhibition	diagnostic test of platelet function	Patients with cardiac arrest and myocardial infarction treated with oral P2Y12 Inhibitor (from the historic cohort of NCT02914795)

Primary Outcome Measures

Name	Time	Method
Platelet inhibition measured with optical aggregometry	4 days	Light transmittance aggregometry

Secondary Outcome Measures

Name	Time	Method
Composite of death and stent thrombosis	4 days	Composite of death and stent thrombosis

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria