Platelet Function in Resuscitated Patients

• Sponsor: Medical University of Graz (Other)
• Overall Status: Completed
• CT.gov ID: NCT02914795
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Actual Duration (Months): 14
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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. 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

Condition or Disease	Intervention/Treatment	Phase
Acute ST Segment Elevation Myocardial Infarction	Other: diagnostic analysis 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 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 99 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Platelet Function in Resuscitated Patients
• Actual Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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; 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	Other: diagnostic analysis of platelet function; analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique

Outcome Measures

Primary Outcome Measures

1. Platelet Inhibition Measured With Optical Aggregometry [day 3]

   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.

Secondary Outcome Measures

1. Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Myocardial infarction

• dual platelet inhibition

• resuscitation

• therapeutic hypothermia

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Graz	Graz		Austria	8010

Sponsors and Collaborators

• Medical University of Graz

Investigators

• Principal Investigator: Dirk von Lewinski, MD, Medical University of Graz

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Medical University of Graz
• ClinicalTrials.gov Identifier: NCT02914795
• Other Study ID Numbers: 27-290ex14/15
• First Posted: Sep 26, 2016
• Last Update Posted: Dec 3, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction

Study Results

Participant Flow

Arm/Group Title	Non-resuscitated Myocardial Infarction	Resuscitated Myocardial Infarction
Arm/Group Description	diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique	diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique
Period Title: Overall Study
STARTED	77	22
COMPLETED	77	22
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Non-resuscitated Myocardial Infarction	Resuscitated Myocardial Infarction	Total
Arm/Group Description	diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique	diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique	Total of all reporting groups
Overall Participants	77	22	99
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	39 50.6%	13 59.1%	52 52.5%
>=65 years	38 49.4%	9 40.9%	47 47.5%
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	64.3	65	64.5
Sex: Female, Male (Count of Participants)
Female	18 23.4%	3 13.6%	21 21.2%
Male	59 76.6%	19 86.4%	78 78.8%
Region of Enrollment (participants) [Number]
Austria	77 100%	22 100%	99 100%
Collagen AUC day 1 (AU*min) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [AU*min]	219	69.5	185.8

Outcome Measures

1. Primary Outcome

Title	Platelet Inhibition Measured With Optical Aggregometry
Description	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.
Time Frame	day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-resuscitated Myocardial Infarction	Resuscitated Myocardial Infarction
Arm/Group Description	diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements	diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements
Measure Participants	77	22
Median (Inter-Quartile Range) [AU*min]	109	253.8

2. Secondary Outcome

Title	Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-resuscitated Myocardial Infarction	Resuscitated Myocardial Infarction
Arm/Group Description	diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique	diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique
Measure Participants	77	22
Count of Participants [Participants]	0 0%	3 13.6%

Adverse Events

Time Frame	7 days
Arm/Group Title	Resuscitated MI		Non Resuscitated MI
Arm/Group Description	Death within the Observation period of 7 days; n=3		Death within the Observation period of 7 days; n=0
All Cause Mortality
	Resuscitated MI		Non Resuscitated MI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/22 (13.6%)		0/77 (0%)
Serious Adverse Events
	Resuscitated MI		Non Resuscitated MI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/77 (0%)
Blood and lymphatic system disorders
High on aspirin platelet reactivity	0/22 (0%)		0/77 (0%)
Other (Not Including Serious) Adverse Events
	Resuscitated MI		Non Resuscitated MI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/77 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.