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
  Purpose

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.


Condition
Coronary Heart Disease

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Impact of Race/Ethnicity on Platelet Function

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 625
Study Start Date: June 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  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: NCT01168622

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Julie H Oestreich, PharmD, PhD University of Nebraska
  More Information

No publications provided

Responsible Party: Julie Oestreich, Pharm D, PhD, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01168622     History of Changes
Other Study ID Numbers: 144-10
Study First Received: June 25, 2010
Last Updated: March 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014