Platelet Function in Resuscitated Patients

NCT02914795 | Completed Results

• 1 other identifier: 27-290ex14/15
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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, 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. 1.oral administration is impossible and medication needs to be administered via a gastric line.
2. 2.gastric absorption is delayed after resuscitation
3. 3.according to current guidelines patients are treated with therapeutic hypothermia. Including the time of rewarming cooling period is \~48h

Conditions

Acute ST Segment Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Platelet Inhibition Measured With Optical Aggregometry

  Median (Inter-Quartile Range) Collagen AUC values on Day 3 measured with optical aggregometry The more light signal is detected, the better thrombocyte function is.

  day 3

Secondary Outcomes (1)

• Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis

  7 days

Study Arms (2)

non-resuscitated myocardial infarction

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

Other: diagnostic analysis of platelet function

resuscitated myocardial infarction

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

Other: diagnostic analysis of platelet function

Interventions

diagnostic analysis of platelet function OTHER

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

non-resuscitated myocardial infarction; resuscitated myocardial infarction

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8010, Austria

Location

Related Publications (6)

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

  PMID: 14737006 BACKGROUND

• 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.

  PMID: 14592562 BACKGROUND

• 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.

  PMID: 12796140 BACKGROUND

• 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.

  PMID: 19550060 BACKGROUND

• 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.

  PMID: 19007592 BACKGROUND

• 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.

  PMID: 30445678 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Assoc. Prof. Dr. Dirk von Lewinski
• Organization: Medical University of Grazt

dirk.von-lewinski@medunigraz.at

+43 316 385

Study Officials

• Dirk von Lewinski, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: September 26, 2016
• Study Start: June 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 3, 2020
• Results First Posted: December 3, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)