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CompletedNCT03445546Updated Jan 26, 2023

Platelet Function in Resuscitated Patients-2

An observational study in Acute Myocardial Infarction and Cardiac Arrest, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-01-26.

Sponsored by Medical University of Graz · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Myocardial Infarction
  • Cardiac Arrest
03

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • none
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • intravenous P2Y12 inhibition

    Patients with cardiac arrest and myocardial infarction treated with intravenous P2Y12 Inhibitor (cangrelor)

    Diagnostic Test: diagnostic test of platelet function

Interventions

  • Diagnostic testdiagnostic test of platelet function

    Light transmittance aggregometry and VerifyNow

05

What researchers measure

Primary outcomes

  1. Platelet inhibition measured with optical aggregometry

    Light transmittance aggregometry

    Time frame: 4 days

Secondary outcomes

  1. Composite of death and stent thrombosis

    Composite of death and stent thrombosis

    Time frame: 4 days

06

Study locations

1 site
  • Medical University of Graz
    Graz, 8036, Austria
07

References and documents

Publications

  • Bhatt DL, Lincoff AM, Gibson CM, Stone GW, McNulty S, Montalescot G, Kleiman NS, Goodman SG, White HD, Mahaffey KW, Pollack CV Jr, Manoukian SV, Widimsky P, Chew DP, Cura F, Manukov I, Tousek F, Jafar MZ, Arneja J, Skerjanec S, Harrington RA; CHAMPION PLATFORM Investigators. Intravenous platelet blockade with cangrelor during PCI. N Engl J Med. 2009 Dec 10;361(24):2330-41. doi: 10.1056/NEJMoa0908629. PubMed 19915222 ↗
  • Angiolillo DJ, Schneider DJ, Bhatt DL, French WJ, Price MJ, Saucedo JF, Shaburishvili T, Huber K, Prats J, Liu T, Harrington RA, Becker RC. Pharmacodynamic effects of cangrelor and clopidogrel: the platelet function substudy from the cangrelor versus standard therapy to achieve optimal management of platelet inhibition (CHAMPION) trials. J Thromb Thrombolysis. 2012 Jul;34(1):44-55. doi: 10.1007/s11239-012-0737-3. PubMed 22569899 ↗
  • White HD, Bhatt DL, Gibson CM, Hamm CW, Mahaffey KW, Price MJ, Steg PG, Stone GW, Cortese B, Wilensky M, Deliargyris EN, Liu T, Prats J, Harrington RA. Outcomes with cangrelor versus clopidogrel on a background of bivalirudin: insights from the CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI]). JACC Cardiovasc Interv. 2015 Mar;8(3):424-433. doi: 10.1016/j.jcin.2014.09.025. Epub 2015 Feb 18. PubMed 25703887 ↗
  • Nolan JP, Soar J, Cariou A, Cronberg T, Moulaert VR, Deakin CD, Bottiger BW, Friberg H, Sunde K, Sandroni C. European Resuscitation Council and European Society of Intensive Care Medicine Guidelines for Post-resuscitation Care 2015: Section 5 of the European Resuscitation Council Guidelines for Resuscitation 2015. Resuscitation. 2015 Oct;95:202-22. doi: 10.1016/j.resuscitation.2015.07.018. No abstract available. PubMed 26477702 ↗
  • Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available. PubMed 26320110 ↗
  • Nikolaou NI, Arntz HR, Bellou A, Beygui F, Bossaert LL, Cariou A; Initial management of acute coronary syndromes section Collaborator. European Resuscitation Council Guidelines for Resuscitation 2015 Section 8. Initial management of acute coronary syndromes. Resuscitation. 2015 Oct;95:264-77. doi: 10.1016/j.resuscitation.2015.07.030. Epub 2015 Oct 15. No abstract available. PubMed 26477416 ↗
  • Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC); Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available. PubMed 22922416 ↗
  • Pruller F, Bis L, Milke OL, Fruhwald F, Patzold S, Altmanninger-Sock S, Siller-Matula J, von Lewinski F, Ablasser K, Sacherer M, von Lewinski D. Cangrelor Induces More Potent Platelet Inhibition without Increasing Bleeding in Resuscitated Patients. J Clin Med. 2018 Nov 15;7(11):442. doi: 10.3390/jcm7110442. PubMed 30445678 ↗
08

Registry details

Key details

Study ID
NCT03445546
Lead sponsor
Medical University of Graz
Responsible party
Sponsor
First posted
Feb 26, 2018
Start date
May 1, 2016
Primary completion
May 15, 2018
Completion
May 15, 2018
Last update
Jan 26, 2023

Study contacts

Dirk von Lewinski, MD
principal investigator · Medical University of Graz

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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