Platelet Function Monitoring in Patients With Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

Official title:

Platelet Function Monitoring in Patients With Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353261
• Other study ID #: TIMING
• Status: Completed
• Phase: N/A
• First received: May 11, 2011
• Last updated: October 31, 2013
• Start date: December 2010
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: Medstar Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	On-treatment platelet reactivity	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.	30 days	No