NCT01353261

Completed

Platelet Function Monitoring in Patients With Acute Myocardi...

Medstar Health Research Institute Source

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Other study identifiers

Sponsor study identifier

TIMING

Study Type

observational

Actual enrollment (reported)

63

Locations

1 country

Sites

1

Timeline

Study Start

December 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2013

Actual (reported)

Study Completion

September 2013

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 63 participants
Study completion date: September 2013
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
May 11, 2011
Actual (reported)
First Posted
May 13, 2011
Actual (reported)
Primary Completion
September 2013
Actual (reported)
Study Completion
September 2013
Actual (reported)

Last Updated: November 1, 2013
Status Verified: October 2013
Last Update Submitted: October 31, 2013

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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

Medstar Health Research Institute
Otherlead

Study Sites (1)

Washington Hospital Center

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

Study Officials

Ron Waksman, MD
Medstar Health Research Institute
PRINCIPAL INVESTIGATOR

Enrollment

63 participants (actual enrollment reported by the registry).

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 2010

Date type not reported

This date has not been verified as actual or estimated.

Completed

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Unknown

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Phase 1/2Completed

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Phase 3Terminated

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.

Contact the study team to confirm eligibility.

Primary Completion

September 2013

Actual (reported)

Study Completion

September 2013

Actual (reported)

Last Updated

November 1, 2013

Record last verified: 2013-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01353261
Data provider: ClinicalTrials.gov
Source updated: 2013-11-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:19 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

Elective Cases

AMI Cases treated with clopidogrel

AMI Cases treated with prasugrel

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations