Impact of Race/Ethnicity on Platelet Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julie Oestreich, Pharm D, PhD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01168622
First received: June 25, 2010
Last updated: March 12, 2013
Last verified: March 2013

June 25, 2010
March 12, 2013
June 2010
March 2013   (final data collection date for primary outcome measure)
Platelet reactivity as measured by platelet function tests [ Time Frame: Platelet reactivity will be assessed at baseline only. No follow-up will occur ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01168622 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Impact of Race/Ethnicity on Platelet Function
Impact of Race/Ethnicity on Platelet Function

The effects of race/ethnicity on platelet function and response to antiplatelet agents will be assessed using 125 healthy subjects, 250 coronary heart disease patients treated with aspirin, and 250 coronary heart disease patients treated with aspirin and a P2Y12 receptor antagonist, clopidogrel or prasugrel. A minimum of 25 healthy people, 50 people taking only aspirin, and 50 people taking aspirin and clopidogrel/prasugrel will be recruited for at least 5 racial/ethnic groups.

Not Provided
Observational
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Blood or saliva samples will be collected for DNA extraction and genotyping of CYP2C19 and other relevant genes.

Non-Probability Sample

Healthy people and coronary heart disease patients taking aspirin or aspirin and clopidogrel or prasugrel

Coronary Heart Disease
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
625
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria: Each subject must fulfill the following criteria in order to be included in the study.

  • The subject must be capable of understanding the nature of the study and executing an informed consent document.
  • The subject must be aged 19 years or older.
  • For healthy subjects, the subject must deny taking any medications that affect platelet function for at least 7 days before blood collection.
  • For diseased patients, subjects with documented CAD are eligible to participate if they have been treated with antiplatelet therapy of aspirin (81 to 325 mg/day) with and without clopidogrel (75 mg/day) or another P2Y12 antagonist for at least one month.

Exclusion Criteria: For healthy volunteers, subjects who fulfill one or more of the following criteria will be excluded from the study.

  • taking medications for chronic cardiovascular diseases.
  • illnesses requiring hospitalization or surgery within the last three months.
  • history of drug or alcohol abuse.
  • history of recent anemia or thrombocytopenia.
  • history of excessive bleeding or thrombosis.
  • pregnancy.

For coronary heart disease subjects, subjects who fulfill one or more of the following criteria will be excluded from the study.

  • illnesses requiring hospitalization or surgery within the last one month.
  • history of drug or alcohol abuse.
  • history of recent anemia or thrombocytopenia.
  • pregnancy.
  • recent bleeding diathesis
  • malignancy
  • renal insufficiency
  • liver dysfunction
  • treatment with warfarin or glycoprotein (GP) IIb/IIIa antagonists during the preceding 14 days
Both
19 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01168622
144-10
No
Julie Oestreich, Pharm D, PhD, University of Nebraska
University of Nebraska
Not Provided
Principal Investigator: Julie H Oestreich, PharmD, PhD University of Nebraska
University of Nebraska
March 2013

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