Platelet Function in Resuscitated Patients-2

January 24, 2023 updated by: Medical University of Graz
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients surviving the first night after resuscitation due to myocardial infarction

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
oral P2Y12 inhibition
Patients with cardiac arrest and myocardial infarction treated with oral P2Y12 Inhibitor (from the historic cohort of NCT02914795)
Diagnostic test: diagnostic test of platelet function
Light transmittance aggregometry and VerifyNow
intravenous P2Y12 inhibition
Patients with cardiac arrest and myocardial infarction treated with intravenous P2Y12 Inhibitor (cangrelor)
Diagnostic test: diagnostic test of platelet function
Light transmittance aggregometry and VerifyNow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet inhibition measured with optical aggregometry
Time Frame: 4 days
Light transmittance aggregometry
4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of death and stent thrombosis
Time Frame: 4 days
Composite of death and stent thrombosis
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Dirk von Lewinski, MD, Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

May 15, 2018

Study Completion (Actual)

May 15, 2018

Study Registration Dates

First Submitted

February 16, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 26, 2018

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28-291 ex15/16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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