Platelet Inhibition in the Acute Phase of STEMI

Acute Myocardial Infarction Clinical Trial

Official title:

Platelet Inhibition in the Acute Phase of ST-segment Elevation Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144819
• Other study ID #: 23374
• Status: Completed
• Phase: N/A
• First received: March 26, 2010
• Last updated: September 6, 2013
• Start date: October 2009
• Est. completion date: August 2010

Study information

• Verified date: September 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Above 18 years of age

• Patients with ST-segment elevation myocardial infarction (STEMI) referred to primary PCI at University Hospital of Aarhus, Skejby.

Exclusion Criteria:

• 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Antiplatelet Therapy
• Infarction
• Myocardial Infarction
• ST-segment Elevation Myocardial Infarction (STEMI)

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Skejby	Aarhus N	Central Denmark Region

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	AP Moeller Foundation

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Primary	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.	Approximately 2-3 months	No
Secondary	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.	Approximately 2-3 months	No
Secondary	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.	Approximately 2-3 months	No
Secondary	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.	Approximately 2-3 months	No
Secondary	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.	Approximately 2-3 months	No
Secondary	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.	Approximately 2-3 months	No
Secondary	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.	Approximately 2-3 months	No