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NCT Number: NCT01144819

Platelet Inhibition in the Acute Phase of STEMI

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.

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Key information

Conditions

Acute Myocardial Infarction Antiplatelet Therapy Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction ST-segment Elevation Myocardial Infarction (STEMI) Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Skejby

Aarhus N, Central Jutland, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

Secondary outcomes

  1. Difference in immature platelet fraction measured by Sysmex® flowcytometry.

    Time frame: Approximately 2-3 months

    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.

  2. Difference in serum P-selectin

    Time frame: Approximately 2-3 months

    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.

  3. Difference in serum trombopoietin

    Time frame: Approximately 2-3 months

    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.

  4. Difference in serum thromboxane B2

    Time frame: Approximately 2-3 months

    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.

  5. Difference in immature platelet fraction measured by Sysmex® flowcytometry.

    Time frame: Approximately 2-3 months

    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.

  6. Difference in immature platelet fraction measured by Sysmex® flowcytometry.

    Time frame: Approximately 2-3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • AP Moeller Foundation

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 16, 2010
Registry last updated
Sep 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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