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Trial record 84 of 512 for:    ASPIRIN AND P2

Platelet Inhibition in the Acute Phase of STEMI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01144819
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : September 9, 2013
Sponsor:
Collaborator:
AP Moeller Foundation
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date March 26, 2010
First Posted Date June 16, 2010
Last Update Posted Date September 9, 2013
Study Start Date October 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 15, 2010)
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01144819 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 15, 2010)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Platelet Inhibition in the Acute Phase of STEMI
Official Title Platelet Inhibition in the Acute Phase of ST-segment Elevation Myocardial Infarction
Brief 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen 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
Sampling Method Non-Probability Sample
Study Population Residents of the Central Denmark Region.
Condition
  • Acute Myocardial Infarction
  • Antiplatelet Therapy
  • ST-segment Elevation Myocardial Infarction (STEMI)
Intervention Not Provided
Study Groups/Cohorts 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 15, 2010)
46
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01144819
Other Study ID Numbers 23374
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Aarhus
Study Sponsor University of Aarhus
Collaborators AP Moeller Foundation
Investigators
Principal Investigator: Steen D Kristensen, MD, DMSc Aarhus University Hospital Skejby
PRS Account University of Aarhus
Verification Date September 2013