Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT02914795
Status:
COMPLETED
Last Update Posted:
2020-12-03
First Post:
2016-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Platelet Function in Resuscitated Patients
Sponsor:
Medical University of Graz
Organization:
Study Overview
Official Title:
Platelet Function in Resuscitated Patients
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: