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Platelet Inhibition in the Acute Phase of STEMI

This study has been completed.
Sponsor:
Collaborator:
AP Moeller Foundation
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01144819
First received: March 26, 2010
Last updated: September 6, 2013
Last verified: September 2013

March 26, 2010
September 6, 2013
October 2009
July 2010   (final data collection date for 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.

Same as current
Complete list of historical versions of study NCT01144819 on ClinicalTrials.gov Archive Site
  • Difference in immature platelet fraction measured by Sysmex® flowcytometry. [ Time Frame: Approximately 2-3 months ] [ Designated as safety issue: No ]

    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.

  • Difference in serum P-selectin [ Time Frame: Approximately 2-3 months ] [ Designated as safety issue: No ]

    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.

  • Difference in serum trombopoietin [ Time Frame: Approximately 2-3 months ] [ Designated as safety issue: No ]

    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.

  • Difference in serum thromboxane B2 [ Time Frame: Approximately 2-3 months ] [ Designated as safety issue: No ]

    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.

  • Difference in immature platelet fraction measured by Sysmex® flowcytometry. [ Time Frame: Approximately 2-3 months ] [ Designated as safety issue: No ]

    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.

  • Difference in immature platelet fraction measured by Sysmex® flowcytometry. [ Time Frame: Approximately 2-3 months ] [ Designated as safety issue: No ]

    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.

Same as current
Not Provided
Not Provided
 
Platelet Inhibition in the Acute Phase of STEMI
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.

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood sample 1:

  • Whole blood (Platelet aggregation tests and flowcytometry)
  • Serum
  • S-Thromboxane B2
  • S-Trombopoeitin
  • S-P-selectin
  • Plasma
  • DNA
  • RNA

Blood sample 2:

  • Whole blood
  • Plasma

Blood sample 3:

  • Whole blood
  • Plasma

Blood sample 4:

  • Whole blood (Platelet aggregation tests and flowcytometry)
  • Serum
  • S-Thromboxane B2
  • S-Trombopoeitin
  • S-P-selectin
  • Plasma
  • DNA
  • RNA
Non-Probability Sample

Residents of the Central Denmark Region.

  • Acute Myocardial Infarction
  • Antiplatelet Therapy
  • ST-segment Elevation Myocardial Infarction (STEMI)
Not Provided
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.
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. 2012 Dec 5. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
August 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01144819
23374
No
University of Aarhus
University of Aarhus
AP Moeller Foundation
Principal Investigator: Steen D Kristensen, MD, DMSc Aarhus University Hospital Skejby
University of Aarhus
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP