Platelet Function Monitoring in Patients With Acute Myocardial Infarction

NCT01353261 | Completed

• 1 other identifier: TIMING
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myocardial Infarction

Keywords

Platelet reactivity

Outcome Measures

Primary Outcomes (1)

• Platelet function

  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.

  30 days

Secondary Outcomes (1)

• On-treatment platelet reactivity

  30 days

Study Arms (3)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Study Officials

• Ron Waksman, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 13, 2011
• Study Start: December 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

US (1)