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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
  Purpose

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.


Condition
Acute Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet Function Monitoring in Patients With Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 63
Study Start Date: December 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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)

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353261

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Research Institute
Investigators
Principal Investigator: Ron Waksman, MD Washington Hospital Center
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01353261     History of Changes
Other Study ID Numbers: TIMING
Study First Received: May 11, 2011
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medstar Research Institute:
Platelet reactivity

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014