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Trial record 26 of 27 for:    cangrelor

Platelet Function in Resuscitated Patients-2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03445546
Recruitment Status : Completed
First Posted : February 26, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Acute Myocardial Infarction Cardiac Arrest Diagnostic Test: diagnostic test of platelet function

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.


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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Platelet Function in Resuscitated Patients-2
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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




Primary Outcome Measures :
  1. Platelet inhibition measured with optical aggregometry [ Time Frame: 4 days ]
    Light transmittance aggregometry


Secondary Outcome Measures :
  1. Composite of death and stent thrombosis [ Time Frame: 4 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients surviving the first night after resuscitation due to myocardial infarction
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445546


Locations
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Austria
Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Dirk von Lewinski, MD Medical University of Graz

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03445546     History of Changes
Other Study ID Numbers: 28-291 ex15/16
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

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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
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases