Acute Myocardial InfarctionNCT01144819
Platelet Inhibition in the Acute Phase of STEMI
An observational study of Acute Myocardial Infarction and Antiplatelet Therapy, run by University of Aarhus at 1 site in Denmark.
Trial summary
Background: Dual antithrombotic treatment with aspirin and clopidogrel is recommended in patients with ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Antiplatelet Therapy, ST-segment Elevation Myocardial Infarction (STEMI)
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2009to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Residents of the Central Denmark Region.
Who may be able to join
- Above 18 years of age
- Patients with ST-segment elevation myocardial infarction (STEMI) referred to primary PCI at University Hospital of Aarhus, Skejby.
Who cannot join
- Treatment with NSAID, ticlopidine and dipyramidole.
- Treatment with anticoagulants (Vitamin K antagonists)
- Patients diagnosed with platelet disease or haemophilia.
- Patients unable to give written, informed consent to participation in this project.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Skejby
Aarhus N, Central Jutland, 8200
About this study
Official title: Platelet Inhibition in the Acute Phase of ST-segment Elevation Myocardial Infarction
Background:
Dual antithrombotic treatment with aspirin and clopidogrel is recommended in patients with ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The European Society of Cardiology (ESC) Guidelines recommend a bolus dose of aspirin of 250-500 mg and a 600 mg bolus dose of clopidogrel as soon as STEMI is suspected. Studies have shown that more newly produced platelets are present in the acute phase of STEMI, and it is likely that these immature platelets are haemostatically more active and might be of importance in thrombus formation.
Read more
The enhanced platelet reactivity may reduce the effect of aspirin and clopidogrel in the acute phase of STEMI compared to measurements made in the same patients 3 months after primary PCI.
Aim:
This study aims to compare platelet response to aspirin and clopidogrel in the acute phase of STEMI with the platelet response in the same patients 3 months after STEMI .
Design:
This study is an observational follow-up study.
Materials and methods:
46 patients with STEMI referred to primary PCI at Aarhus University Hospital, Skejby will be included in the study. A total of 3 blood samples are obtained in the acute phase of STEMI: Prior to primary PCI (Blood sample 1), at 4 hours (Blood sample 2) and at 12 hours (Blood sample 3) after administration of loading dose aspirin and clopidogrel. When patients are in a stable phase 3 month later, a final blood sample is taken (Blood sample 4). The blood is analyzed 30 minutes after withdrawal of blood by the platelet aggregation test Multiplate® aggregometry (agonists: Collagen, arachidonic acid and adenosinediphosphate) and VerifyNow® arachidonic acid and P2Y12 aggregometry. Platelet count, volume and the immature platelet fraction (IPF) will be measured using Sysmex® flowcytometry.
- Conditions
- Acute Myocardial Infarction, Antiplatelet Therapy, ST-segment Elevation Myocardial Infarction (STEMI)
- Keywords
- STEMI, Acute myocardial infarction, Antiplatelet therapy, aspirin, clopidogrel, VerifyNow aggregometry, Multiplate aggregometry
- 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.
| Study group | Role | What they receive |
|---|---|---|
| STEMI | Patients with STEMI according to ESC STEMI guidelines: Age above 18 years and able to give written, informed consent to participation in the project. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between aggregation induced by agonist collagen (1 μg/ml) measured by Multiplate® Aggregometry (Unit=AUC).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 1: Obtained immediately before primary PCI in the catherization laboratory. The blood sample is obtained from the femoral artery catheter.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation induced by agonist collagen (1 μg/ml) measured by Multiplate® Aggregometry (Unit=AUC).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 2: 4 hours after administration of loading dose (LD) aspirin and clopidogrel.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation induced by agonist collagen (1 μg/ml) measured by Multiplate® Aggregometry (Unit=AUC).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation induced by agonist arachidonic acid (1,0 mM) measured by Multiplate® Aggregometry (Unit=AUC).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 1: Obtained immediately before primary PCI in the catherization laboratory. The blood sample is obtained from the femoral artery catheter.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation induced by agonist arachidonic acid (1,0 mM) measured by Multiplate® Aggregometry (Unit=AUC).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 2: 4 hours after administration of loading dose (LD) aspirin and clopidogrel.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation induced by agonist arachidonic acid (1,0 mM) measured by Multiplate® Aggregometry (Unit=AUC).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation induced by agonist adenosine diphosphate (6,4 µM) measured by Multiplate® Aggregometry (Unit=AUC).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 1: Obtained immediately before primary PCI in the catherization laboratory. The blood sample is obtained from the femoral artery catheter.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation induced by agonist adenosine diphosphate (6,4 µM) measured by Multiplate® Aggregometry (Unit=AUC).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 2: 4 hours after administration of loading dose (LD) aspirin and clopidogrel.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation induced by agonist adenosine diphosphate (6,4 µM) measured by Multiplate® Aggregometry (Unit=AUC).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation induced by agonist adenosine diphosphate (20 µM) measured by Multiplate® Aggregometry (Unit=AUC).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 1: Obtained immediately before primary PCI in the catherization laboratory. The blood sample is obtained from the femoral artery catheter.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation induced by agonist adenosine diphosphate (20 µM) measured by Multiplate® Aggregometry (Unit=AUC).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 2: 4 hours after administration of loading dose (LD) aspirin and clopidogrel.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation induced by agonist adenosine diphosphate (20 µM) measured by Multiplate® Aggregometry (Unit=AUC).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation measured by VerifyNow® Aggregometry using the ASPI-kit (Unit = ARU).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 1: Obtained immediately before primary PCI in the catherization laboratory. The blood sample is obtained from the femoral artery catheter.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation measured by VerifyNow® Aggregometry using the ASPI-kit (Unit = ARU).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 2: 4 hours after administration of loading dose (LD) aspirin and clopidogrel.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation measured by VerifyNow® Aggregometry using the ASPI-kit (Unit = ARU).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation measured by VerifyNow® Aggregometry using the P2Y12-kit (Unit = PRU).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 1: Obtained immediately before primary PCI in the catherization laboratory. The blood sample is obtained from the femoral artery catheter.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation measured by VerifyNow® Aggregometry using the P2Y12-kit (Unit = PRU).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 2: 4 hours after administration of loading dose (LD) aspirin and clopidogrel.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference between aggregation measured by VerifyNow® Aggregometry using the P2Y12-kit (Unit = PRU).
Outcome is the difference between aggregation measurements. In this case between:
Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Secondary outcomes (6)
Difference in immature platelet fraction measured by Sysmex® flowcytometry.
Outcome is the difference between measurements. In this case between:
Blood sample 1: Obtained immediately before primary PCI in the catherization laboratory. The blood sample is obtained from the femoral artery catheter.
Blood sample 4: 2-3 months after administration of LD aspirin and clopidogrel.
Measured: Approximately 2-3 months
Difference in serum P-selectin
Outcome is the difference between measurements. In this case between:
Blood sample 1: Obtained immediately before primary PCI in the catherization laboratory. The blood sample is obtained from the femoral artery catheter.
Blood sample 4: 2-3 months after administration of LD aspirin and clopidogrel.
Measured: Approximately 2-3 months
Difference in serum trombopoietin
Outcome is the difference between measurements. In this case between:
Blood sample 1: Obtained immediately before primary PCI in the catherization laboratory. The blood sample is obtained from the femoral artery catheter.
Blood sample 4: 2-3 months after administration of LD aspirin and clopidogrel.
Measured: Approximately 2-3 months
Difference in serum thromboxane B2
Outcome is the difference between measurements. In this case between:
Blood sample 1: Obtained immediately before primary PCI in the catherization laboratory. The blood sample is obtained from the femoral artery catheter.
Blood sample 4: 2-3 months after administration of LD aspirin and clopidogrel.
Measured: Approximately 2-3 months
Difference in immature platelet fraction measured by Sysmex® flowcytometry.
Outcome is the difference between measurements. In this case between:
Blood sample 2: 4 hours after administration of loading dose (LD) aspirin and clopidogrel.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Difference in immature platelet fraction measured by Sysmex® flowcytometry.
Outcome is the difference between measurements. In this case between:
Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel.
Blood sample 4: 2-3 months after primary PCI.
Measured: Approximately 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- AP Moeller Foundation
- Responsible party
- Sponsor
- Investigators
- Steen D Kristensen, MD, DMSc, Principal investigator, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144819
- Sponsor's protocol ID
- 23374
- Status last verified
- Sep 2013
- First submitted
- 26 Mar 2010
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Funck-Jensen KL, Dalsgaard J, Grove EL, Hvas AM, Kristensen SD. Increased platelet aggregation and turnover in the acute phase of ST-elevation myocardial infarction. Platelets. 2013;24(7):528-37. doi: 10.3109/09537104.2012.738838. Epub 2012 Dec 5.
PubMed 23216571
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Inhibition in the Acute Phase of ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01144819
- Acronym / sponsor ID
- 23374
- Conditions
- Acute Myocardial Infarction, Antiplatelet Therapy, ST-segment Elevation Myocardial Infarction (STEMI)
- Keywords
- STEMI, Acute myocardial infarction, Antiplatelet therapy, aspirin, clopidogrel, VerifyNow aggregometry, Multiplate aggregometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- AP Moeller Foundation
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 16 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Dual antithrombotic treatment with aspirin and clopidogrel is recommended in patients with ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The European Society of Cardiology (ESC) Guidelines recommend a bolus dose of aspirin of 250-500 mg and a 600 mg bolus dose of clopidogrel as soon as STEMI is suspected. Studies have shown that more newly produced platelets are present in the acute phase of STEMI, and it is likely that these immature platelets are haemostatically more active and might be of importance in thrombus formation.
The enhanced platelet reactivity may reduce the effect of aspirin and clopidogrel in the acute phase of STEMI compared to measurements made in the same patients 3 months after primary PCI.
Aim:
This study aims to compare platelet response to aspirin and clopidogrel in the acute phase of STEMI with the platelet response in the same patients 3 months after STEMI .
Design:
This study is an observational follow-up study.
Materials and methods:
46 patients with STEMI referred to primary PCI at Aarhus University Hospital, Skejby will be included in the study. A total of 3 blood samples are obtained in the acute phase of STEMI: Prior to primary PCI (Blood sample 1), at 4 hours (Blood sample 2) and at 12 hours (Blood sample 3) after administration of loading dose aspirin and clopidogrel. When patients are in a stable phase 3 month later, a final blood sample is taken (Blood sample 4). The blood is analyzed 30 minutes after withdrawal of blood by the platelet aggregation test Multiplate® aggregometry (agonists: Collagen, arachidonic acid and adenosinediphosphate) and VerifyNow® arachidonic acid and P2Y12 aggregometry. Platelet count, volume and the immature platelet fraction (IPF) will be measured using Sysmex® flowcytometry.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI | – | –Patients with STEMI according to ESC STEMI guidelines: Age above 18 years and able to give written, informed consent to participation in the project. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of the Central Denmark Region.
Key inclusion criteria (2 listed)
- Above 18 years of age
- Patients with ST-segment elevation myocardial infarction (STEMI) referred to primary PCI at University Hospital of Aarhus, Skejby.
Key exclusion criteria (4 listed)
- Treatment with NSAID, ticlopidine and dipyramidole.
- Treatment with anticoagulants (Vitamin K antagonists)
- Patients diagnosed with platelet disease or haemophilia.
- Patients unable to give written, informed consent to participation in this project.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference between aggregation induced by agonist collagen (1 μg/ml) measured by Multiplate® Aggregometry (Unit=AUC).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 1: Obtained immediately before primary PCI in the catherization laboratory. The blood sample is obtained from the femoral artery catheter. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation induced by agonist collagen (1 μg/ml) measured by Multiplate® Aggregometry (Unit=AUC).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 2: 4 hours after administration of loading dose (LD) aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation induced by agonist collagen (1 μg/ml) measured by Multiplate® Aggregometry (Unit=AUC).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation induced by agonist arachidonic acid (1,0 mM) measured by Multiplate® Aggregometry (Unit=AUC).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 1: Obtained immediately before primary PCI in the catherization laboratory. The blood sample is obtained from the femoral artery catheter. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation induced by agonist arachidonic acid (1,0 mM) measured by Multiplate® Aggregometry (Unit=AUC).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 2: 4 hours after administration of loading dose (LD) aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation induced by agonist arachidonic acid (1,0 mM) measured by Multiplate® Aggregometry (Unit=AUC).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation induced by agonist adenosine diphosphate (6,4 µM) measured by Multiplate® Aggregometry (Unit=AUC).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 1: Obtained immediately before primary PCI in the catherization laboratory. The blood sample is obtained from the femoral artery catheter. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation induced by agonist adenosine diphosphate (6,4 µM) measured by Multiplate® Aggregometry (Unit=AUC).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 2: 4 hours after administration of loading dose (LD) aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation induced by agonist adenosine diphosphate (6,4 µM) measured by Multiplate® Aggregometry (Unit=AUC).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation induced by agonist adenosine diphosphate (20 µM) measured by Multiplate® Aggregometry (Unit=AUC).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 1: Obtained immediately before primary PCI in the catherization laboratory. The blood sample is obtained from the femoral artery catheter. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation induced by agonist adenosine diphosphate (20 µM) measured by Multiplate® Aggregometry (Unit=AUC).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 2: 4 hours after administration of loading dose (LD) aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation induced by agonist adenosine diphosphate (20 µM) measured by Multiplate® Aggregometry (Unit=AUC).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation measured by VerifyNow® Aggregometry using the ASPI-kit (Unit = ARU).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 1: Obtained immediately before primary PCI in the catherization laboratory. The blood sample is obtained from the femoral artery catheter. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation measured by VerifyNow® Aggregometry using the ASPI-kit (Unit = ARU).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 2: 4 hours after administration of loading dose (LD) aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation measured by VerifyNow® Aggregometry using the ASPI-kit (Unit = ARU).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation measured by VerifyNow® Aggregometry using the P2Y12-kit (Unit = PRU).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 1: Obtained immediately before primary PCI in the catherization laboratory. The blood sample is obtained from the femoral artery catheter. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation measured by VerifyNow® Aggregometry using the P2Y12-kit (Unit = PRU).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 2: 4 hours after administration of loading dose (LD) aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation measured by VerifyNow® Aggregometry using the P2Y12-kit (Unit = PRU).
Time frame: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
6 secondary outcomes
Difference in immature platelet fraction measured by Sysmex® flowcytometry.
Time frame: Approximately 2-3 months
Difference in serum P-selectin
Time frame: Approximately 2-3 months
Difference in serum trombopoietin
Time frame: Approximately 2-3 months
Difference in serum thromboxane B2
Time frame: Approximately 2-3 months
Difference in immature platelet fraction measured by Sysmex® flowcytometry.
Time frame: Approximately 2-3 months
Difference in immature platelet fraction measured by Sysmex® flowcytometry.
Time frame: Approximately 2-3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
- Results publication: PubMed 23216571Funck-Jensen KL, Dalsgaard J, Grove EL, Hvas AM, Kristensen SD. Increased platelet aggregation and turnover in the acute phase of ST-elevation myocardial infarction. Platelets. 2013;24(7):528-37. doi: 10.3109/09537104.2012.738838. Epub 2012 Dec 5.
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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.
Steen D Kristensen, MD, DMSc principal investigator
Aarhus University Hospital Skejby
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 Myocardial Infarction and Antiplatelet Therapy, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 4 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 9 Sep 2013. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference between aggregation induced by agonist collagen (1 μg/ml) measured by Multiplate® Aggregometry (Unit=AUC). (time frame: Approximately 2-3 months). The study lists 18 primary outcomes in all. 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 NCT01144819, which also lists 1 linked publication.
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 9 Sep 2013.