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. 02/09/2022 02/09/2022 - Niko Möller-Grell
  2. 12/10/2022 12/10/2022 - Adrian Schulz
Titular dos direitos

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

Transferido a

12 de outubro 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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