Platelet Function in Resuscitated Patients

Acute ST Segment Elevation Myocardial Infarction Clinical Trial

Official title:

Platelet Function in Resuscitated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02914795
• Other study ID #: 27-290ex14/15
• Status: Completed
• Start date: June 2015
• Est. completion date: August 2016

Study information

• Verified date: December 2020
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. 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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Myocardial infarction

• dual platelet inhibition

• resuscitation

• therapeutic hypothermia

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Acute ST Segment Elevation Myocardial Infarction
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Other:
• diagnostic analysis of platelet function
analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (5)

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. Epub 2003 Jun 9. — View Citation

McNicol A, Israels SJ. Platelets and anti-platelet therapy. J Pharmacol Sci. 2003 Dec;93(4):381-96. Review. — View Citation

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. — View Citation

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. — View Citation

Tendera M, Wojakowski W. Role of antiplatelet drugs in the prevention of cardiovascular events. Thromb Res. 2003 Jun 15;110(5-6):355-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis		7 days