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Platelet Function Monitoring in Patients With Acute Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01353261
First received: May 11, 2011
Last updated: October 31, 2013
Last verified: October 2013

May 11, 2011
October 31, 2013
December 2010
September 2013   (final data collection date for primary outcome measure)
Platelet function [ Time Frame: 30 days ] [ Designated as safety issue: No ]
The primary endpoint will be whether the results of platelet function assays used to measure response to clopidogrel and prasugrel therapy is similar amongst patients with stable CAD and those with AMI undergoing PCI. On-treatment platelet reactivity will be measured using the VerifyNow P2Y12 assay.
Platelet function [ Time Frame: 30 days ] [ Designated as safety issue: No ]
The primary endpoint will be whether the results of platelet function assays used to measure response to clopidogrel therapy is similar amongst patients with stable CAD and those with AMI undergoing PCI. On-treatment platelet reactivity will be measured using the VerifyNow P2Y12 assay.
Complete list of historical versions of study NCT01353261 on ClinicalTrials.gov Archive Site
On-treatment platelet reactivity [ Time Frame: 30 days ] [ Designated as safety issue: No ]

A secondary endpoint will be to determine on-treatment platelet reactivity at the same time points using:

  • The vasodilator-stimulated phosphoprotein (VASP) phosphorylation assay; and/or
  • The Chrono-Log Lumi-Aggregometer, which measures platelet aggregation (via optical density or electrical impedance) in response to ADP stimulation.
Same as current
Not Provided
Not Provided
 
Platelet Function Monitoring in Patients With Acute Myocardial Infarction
Platelet Function Monitoring in Patients With Acute Myocardial Infarction

This study is being done to learn more about platelet reactivity (how well the small cells in the bloodstream work) in people who undergo Percutaneous coronary intervention (PCI) for stable and unstable (acute myocardial infarction) indications. Stable means you have not demonstrated any acute injury to your heart prior to your PCI; unstable means you have demonstrated some acute injury to your heart prior to your PCI. The investigators intend to determine if there is a change in platelet reactivity from the time of PCI to 30days post-PCI and does this change differ depending upon the conduction in which you present for PCI. This is going to be done with a variety of platelet reactivity assays.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Seventy five subjects (25 patients undergoing elective PCI for stable CAD and 50 patients undergoing urgent PCI for AMI(25 receiving clopidogrel and 25 receiving prasugrel - as determined by the treating physicians)

Acute Myocardial Infarction
Not Provided
  • Elective Cases
    Patients with stable CAD undergoing PCI
  • AMI Cases treated with clopidogrel
    Patient with AMI undergoing PCI
  • AMI Cases treated with prasugrel
    Patients with AMI undergoing PCI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient >18 years old.
  • Patient scheduled to undergo PCI for either stable CAD or AMI:
  • Stable CAD defined as negative cardiac isoenzymes prior to the PCI as well as no resting ECG changes indicative of ACS.
  • AMI defined as positive cardiac isoenzymes prior to the PCI and/or resting ECG changes indicative of ACS.

    3. Patients treated with a loading dose of clopidogrel at least 6 hours prior to the blood draw or on a maintenance dose of clopidogrel (of at least 75mg QD) for a minimum of 5 days.

Exclusion Criteria:

  • Known allergies to aspirin, clopidogrel, or prasugrel
  • Use of a glycoprotein (GP) IIb/IIIa inhibitor within 8 hours of the blood draw;
  • Patient known to be pregnant or lactating;
  • Patient with known history of bleeding diathesis or currently active bleeding;
  • Platelet count <100,000/mm the day of the blood draw;
  • Hematocrit <25% the day of the blood draw;
  • On warfarin therapy at the time of the blood draw or the need for warfarin therapy in the subsequent month following the blood draw;
  • Known blood transfusion within the preceding 10 days of the blood draw;
  • Patient who has received NSAID (not including ASA) within preceding 24 hours of the blood draw;
  • Patients presenting with cardiogenic shock;
  • Any significant medical condition, which in the investigator's opinion may interfere with the patient's optimal participation in the study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01353261
TIMING
No
Medstar Research Institute
Medstar Research Institute
Not Provided
Principal Investigator: Ron Waksman, MD Washington Hospital Center
Medstar Research Institute
October 2013

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