0 Avaliações

ID

45157

Descrição

Principal Investigator: Alan Shuldiner, MD, University of Maryland Baltimore, Baltimore, MD, USA MeSH: Pharmacogenomics,Clopidogrel,Platelets https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000391 CHD is the leading cause of death in the United States. One of the most common ways to prevent CHD is to take an anti-platelet agent, which lessens platelet aggregation. Two of the most common anti-platelet agents are aspirin and clopidogrel. However, up to 25% to 30% of people do not respond to these medications. Evidence indicates that treatment response may be related to genetics. The purpose of this study is to determine specific gene variants that predict response to aspirin and clopidogrel therapy. This study is part of a larger group of studies called the Pharmacogenomics Research Network (PGRN). Participants are from the Old Order Amish of Lancaster, Pennsylvania. They are well suited for genetic studies because they are a homogenous, closed, founder population. Participants received 300 mg of clopidogrel on the first day, then 75 mg of clopidogrel per day for the next 6 days. On the last day of clopidogrel treatment, participants took a single dose of 324 mg aspirin. Participants underwent platelet function tests before and after clopidogrel alone, and then again after taking clopidogrel plus aspirin. Using the gene variation profiles across the genome, researchers analyzed which variants correspond to treatment response.

Link

dbGaP study = phs000391

Palavras-chave

  1. 2/9/22 2/9/22 - Niko Möller-Grell
  2. 12/10/22 12/10/22 - Adrian Schulz
Titular dos direitos

Alan Shuldiner, MD, University of Maryland Baltimore, Baltimore, MD, USA

Transferido a

12 de octubre de 2022

DOI

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Licença

Creative Commons BY 4.0

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    dbGaP phs000391 Pharmacogenomics of Anti-Platelet Intervention (PAPI) Study

    Eligibility Criteria

    Inclusion and exclusion criteria
    Descrição

    Inclusion and exclusion criteria

    Inclusion Criteria:
    Descrição

    Elig.phs000391.v1.p1.1

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    Of Old Order Amish descent
    Descrição

    Elig.phs000391.v1.p1.2

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0238622
    At least 20 years old
    Descrição

    Elig.phs000391.v1.p1.3

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C4323877
    Exclusion Criteria:
    Descrição

    Elig.phs000391.v1.p1.4

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    Currently pregnant or less than 6 months have passed since delivery
    Descrição

    Elig.phs000391.v1.p1.5

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0549206
    UMLS CUI [2,1]
    C0439092
    UMLS CUI [2,2]
    C4082120
    UMLS CUI [2,3]
    C0086839
    History of a bleeding disorder or major spontaneous bleed, such as peptic ulcer, epistasis, or intracranial bleed
    Descrição

    Elig.phs000391.v1.p1.6

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0005779
    UMLS CUI [2,1]
    C1321132
    Severe hypertension, defined by a blood pressure above 160/95 mm Hg, making it unethical not to recommend prompt treatment
    Descrição

    Elig.phs000391.v1.p1.7

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C4013784
    Medications that would affect the outcome(s) to be measured and cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation
    Descrição

    Elig.phs000391.v1.p1.8

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C4717992
    UMLS CUI [1,2]
    C1319171
    UMLS CUI [1,3]
    C0392747
    UMLS CUI [1,4]
    C93407
    Vitamins or other supplements and is unwilling to discontinue their use for at least 1 week prior to study
    Descrição

    Elig.phs000391.v1.p1.9

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0242295
    UMLS CUI [1,2]
    C1548265
    Coexisting malignancy
    Descrição

    Elig.phs000391.v1.p1.10

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C4482549
    UMLS CUI [1,2]
    C0006826
    Creatinine level greater than 2.0 mg/dl, aspartate transaminase (AST) or alanine transaminase (ALT) greater than two times the upper limit of normal, hematocrit less than 32%, or a thyroid-stimulating hormone (TSH) less than 0.4 or greater than 5.5 mIU/L
    Descrição

    Elig.phs000391.v1.p1.11

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C5557309
    UMLS CUI [2,1]
    C0580476
    UMLS CUI [3,1]
    C0151905
    UMLS CUI [4,1]
    C1295607
    UMLS CUI [5,1]
    C0586553
    Bleeding disorder or history of gastrointestinal bleeding or other major bleeding episode
    Descrição

    Elig.phs000391.v1.p1.12

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0005779
    UMLS CUI [2,1]
    C0262926
    UMLS CUI [2,2]
    C0017181
    UMLS CUI [3,1]
    C0262926
    UMLS CUI [3,2]
    C0019080
    Currently taking aspirin, clopidogrel, or other anti-coagulant, such as warfarin, heparin, or GPIIb/IIIa antagonists, and have conditions that might place them at increased risk from withdrawal of these medications 14 days prior to protocol initiation, including history of unstable angina, heart attack, angioplasty (including stent placement), coronary artery bypass surgery, atrial fibrillation, stroke or transient ischemic attacks, diabetes, or deep vein thrombosis or other thrombosis
    Descrição

    Elig.phs000391.v1.p1.13

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0150457
    UMLS CUI [1,2]
    C0558681
    UMLS CUI [1,3]
    C5545962
    Polycythemia, or thrombocytosis, defined by a platelet count greater than 500,000
    Descrição

    Elig.phs000391.v1.p1.14

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0032461
    UMLS CUI [2,1]
    C0836924
    Thrombocytopenia, defined by a platelet count less than 75,000
    Descrição

    Elig.phs000391.v1.p1.15

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0040034
    Surgery within the last 6 months
    Descrição

    Elig.phs000391.v1.p1.16

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0744961
    UMLS CUI [1,2]
    C0205156
    UMLS CUI [1,3]
    C4082120
    Aspirin or clopidogrel allergy
    Descrição

    Elig.phs000391.v1.p1.17

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0004058
    UMLS CUI [2,1]
    C1689910
    Currently breast feeding
    Descrição

    Elig.phs000391.v1.p1.18

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0006147

    Similar models

    Eligibility Criteria

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Inclusion and exclusion criteria
    Elig.phs000391.v1.p1.1
    Item
    Inclusion Criteria:
    boolean
    C1512693 (UMLS CUI [1,1])
    Elig.phs000391.v1.p1.2
    Item
    Of Old Order Amish descent
    boolean
    C0238622 (UMLS CUI [1,1])
    Elig.phs000391.v1.p1.3
    Item
    At least 20 years old
    boolean
    C4323877 (UMLS CUI [1,1])
    Elig.phs000391.v1.p1.4
    Item
    Exclusion Criteria:
    boolean
    C0680251 (UMLS CUI [1,1])
    Elig.phs000391.v1.p1.5
    Item
    Currently pregnant or less than 6 months have passed since delivery
    boolean
    C0549206 (UMLS CUI [1,1])
    C0439092 (UMLS CUI [2,1])
    C4082120 (UMLS CUI [2,2])
    C0086839 (UMLS CUI [2,3])
    Elig.phs000391.v1.p1.6
    Item
    History of a bleeding disorder or major spontaneous bleed, such as peptic ulcer, epistasis, or intracranial bleed
    boolean
    C0005779 (UMLS CUI [1,1])
    C1321132 (UMLS CUI [2,1])
    Elig.phs000391.v1.p1.7
    Item
    Severe hypertension, defined by a blood pressure above 160/95 mm Hg, making it unethical not to recommend prompt treatment
    boolean
    C4013784 (UMLS CUI [1,1])
    Elig.phs000391.v1.p1.8
    Item
    Medications that would affect the outcome(s) to be measured and cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation
    boolean
    C4717992 (UMLS CUI [1,1])
    C1319171 (UMLS CUI [1,2])
    C0392747 (UMLS CUI [1,3])
    C93407 (UMLS CUI [1,4])
    Elig.phs000391.v1.p1.9
    Item
    Vitamins or other supplements and is unwilling to discontinue their use for at least 1 week prior to study
    boolean
    C0242295 (UMLS CUI [1,1])
    C1548265 (UMLS CUI [1,2])
    Elig.phs000391.v1.p1.10
    Item
    Coexisting malignancy
    boolean
    C4482549 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    Elig.phs000391.v1.p1.11
    Item
    Creatinine level greater than 2.0 mg/dl, aspartate transaminase (AST) or alanine transaminase (ALT) greater than two times the upper limit of normal, hematocrit less than 32%, or a thyroid-stimulating hormone (TSH) less than 0.4 or greater than 5.5 mIU/L
    boolean
    C5557309 (UMLS CUI [1,1])
    C0580476 (UMLS CUI [2,1])
    C0151905 (UMLS CUI [3,1])
    C1295607 (UMLS CUI [4,1])
    C0586553 (UMLS CUI [5,1])
    Elig.phs000391.v1.p1.12
    Item
    Bleeding disorder or history of gastrointestinal bleeding or other major bleeding episode
    boolean
    C0005779 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [2,1])
    C0017181 (UMLS CUI [2,2])
    C0262926 (UMLS CUI [3,1])
    C0019080 (UMLS CUI [3,2])
    Elig.phs000391.v1.p1.13
    Item
    Currently taking aspirin, clopidogrel, or other anti-coagulant, such as warfarin, heparin, or GPIIb/IIIa antagonists, and have conditions that might place them at increased risk from withdrawal of these medications 14 days prior to protocol initiation, including history of unstable angina, heart attack, angioplasty (including stent placement), coronary artery bypass surgery, atrial fibrillation, stroke or transient ischemic attacks, diabetes, or deep vein thrombosis or other thrombosis
    boolean
    C0150457 (UMLS CUI [1,1])
    C0558681 (UMLS CUI [1,2])
    C5545962 (UMLS CUI [1,3])
    Elig.phs000391.v1.p1.14
    Item
    Polycythemia, or thrombocytosis, defined by a platelet count greater than 500,000
    boolean
    C0032461 (UMLS CUI [1,1])
    C0836924 (UMLS CUI [2,1])
    Elig.phs000391.v1.p1.15
    Item
    Thrombocytopenia, defined by a platelet count less than 75,000
    boolean
    C0040034 (UMLS CUI [1,1])
    Elig.phs000391.v1.p1.16
    Item
    Surgery within the last 6 months
    boolean
    C0744961 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    C4082120 (UMLS CUI [1,3])
    Elig.phs000391.v1.p1.17
    Item
    Aspirin or clopidogrel allergy
    boolean
    C0004058 (UMLS CUI [1,1])
    C1689910 (UMLS CUI [2,1])
    Elig.phs000391.v1.p1.18
    Item
    Currently breast feeding
    boolean
    C0006147 (UMLS CUI [1,1])

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