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Platelet Function in Resuscitated Patients

NCT ID: NCT02914795

Last Updated: 2020-12-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Acute ST Segment Elevation Myocardial Infarction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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non-resuscitated myocardial infarction

diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial

diagnostic analysis of platelet function

Intervention Type OTHER

analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique

resuscitated myocardial infarction

diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria

diagnostic analysis of platelet function

Intervention Type OTHER

analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique

Interventions

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diagnostic analysis of platelet function

analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dirk von Lewinski, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

References

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McNicol A, Israels SJ. Platelets and anti-platelet therapy. J Pharmacol Sci. 2003 Dec;93(4):381-96. doi: 10.1254/jphs.93.381.

Reference Type BACKGROUND
PMID: 14737006 (View on PubMed)

Tendera M, Wojakowski W. Role of antiplatelet drugs in the prevention of cardiovascular events. Thromb Res. 2003 Jun 15;110(5-6):355-9. doi: 10.1016/j.thromres.2003.08.003.

Reference Type BACKGROUND
PMID: 14592562 (View on PubMed)

Gurbel PA, Bliden KP, Hiatt BL, O'Connor CM. Clopidogrel for coronary stenting: response variability, drug resistance, and the effect of pretreatment platelet reactivity. Circulation. 2003 Jun 17;107(23):2908-13. doi: 10.1161/01.CIR.0000072771.11429.83. Epub 2003 Jun 9.

Reference Type BACKGROUND
PMID: 12796140 (View on PubMed)

Puri KS, Suresh KR, Gogtay NJ, Thatte UM. Declaration of Helsinki, 2008: implications for stakeholders in research. J Postgrad Med. 2009 Apr-Jun;55(2):131-4. doi: 10.4103/0022-3859.52846.

Reference Type BACKGROUND
PMID: 19550060 (View on PubMed)

Siller-Matula JM, Lang I, Christ G, Jilma B. Calcium-channel blockers reduce the antiplatelet effect of clopidogrel. J Am Coll Cardiol. 2008 Nov 4;52(19):1557-63. doi: 10.1016/j.jacc.2008.07.055.

Reference Type BACKGROUND
PMID: 19007592 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30445678 (View on PubMed)

Other Identifiers

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27-290ex14/15

Identifier Type: -

Identifier Source: org_study_id