Acute ST Segment Elevation Myocardial InfarctionNCT02914795
Platelet Function in Resuscitated Patients
An observational study of Acute ST Segment Elevation Myocardial Infarction, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute ST Segment Elevation Myocardial Infarction
- What is being tested?
- diagnostic analysis of platelet function
- How many people
- 99 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2015to Aug 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients surviving the first night after resuscitation due to myocardial infarction
Who may be able to join
- Myocardial infarction
- dual platelet inhibition
- resuscitation
- therapeutic hypothermia
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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:
- oral administration is impossible and medication needs to be administered via a gastric line.
- gastric absorption is delayed after resuscitation
- according to current guidelines patients are treated with therapeutic hypothermia. Including the time of rewarming cooling period is ~48h
Read the 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.
- Being tested
- diagnostic analysis of platelet function
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic analysis of platelet functionOther
analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique
| Study group | Role | What they receive |
|---|---|---|
| non-resuscitated myocardial infarction | diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial Receives: Other: diagnostic analysis of platelet function | |
| resuscitated myocardial infarction | diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria Receives: Other: diagnostic analysis of platelet function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 3
Secondary outcomes (1)
Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startJun 2015
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute ST Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk von Lewinski, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914795
- Sponsor's protocol ID
- 27-290ex14/15
- Status last verified
- Dec 2020
- First submitted
- 12 May 2016
- Last updated
- 3 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
McNicol A, Israels SJ. Platelets and anti-platelet therapy. J Pharmacol Sci. 2003 Dec;93(4):381-96. doi: 10.1254/jphs.93.381.
PubMed 14737006Tendera 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.
PubMed 14592562Gurbel 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.
PubMed 12796140Puri 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.
PubMed 19550060Siller-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.
PubMed 19007592Pruller 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.
PubMed 30445678
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Function in Resuscitated Patients
- ClinicalTrials.gov ID
- NCT02914795
- Acronym / sponsor ID
- 27-290ex14/15
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Posted 3 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- oral administration is impossible and medication needs to be administered via a gastric line.
- gastric absorption is delayed after resuscitation
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-resuscitated myocardial infarction | – | Other: diagnostic analysis of platelet functiondiagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial |
| resuscitated myocardial infarction | – | Other: diagnostic analysis of platelet functiondiagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients surviving the first night after resuscitation due to myocardial infarction
Key inclusion criteria (4 listed)
- Myocardial infarction
- dual platelet inhibition
- resuscitation
- therapeutic hypothermia
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnostic analysis of platelet functionanalysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique | Other | non-resuscitated myocardial infarction, resuscitated myocardial infarction |
Primary outcome
Platelet Inhibition Measured With Optical Aggregometry
Time frame: 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.
1 secondary outcome
Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14737006McNicol A, Israels SJ. Platelets and anti-platelet therapy. J Pharmacol Sci. 2003 Dec;93(4):381-96. doi: 10.1254/jphs.93.381.
- Background: PubMed 14592562Tendera 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.
- Background: PubMed 12796140Gurbel 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.
- Background: PubMed 19550060Puri 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.
- Background: PubMed 19007592Siller-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.
- Derived from this study: PubMed 30445678Pruller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk von Lewinski, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute ST Segment Elevation Myocardial Infarction, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Inhibition Measured With Optical Aggregometry (time frame: day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02914795, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.