0 Ratings
ID

44478

Description

Reduced Dose of Unfractionated Heparin in Patients Undergoing PCI; ODM derived from: https://clinicaltrials.gov/show/NCT00735280

Link

https://clinicaltrials.gov/show/NCT00735280

Keywords

Versions (2)
  1. 1/19/18 1/19/18 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

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September 27, 2021

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License

Creative Commons BY 4.0
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    Eligibility Coronary Artery Disease NCT00735280

    English

    Eligibility Coronary Artery Disease NCT00735280

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients older than 18 years undergoing a pci procedure
    Description

    Age | Percutaneous Coronary Intervention

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C1532338
    2. pretreatment with 600mg clopidogrel at least 2 hours before the intervention
    Description

    Pretreatment Intervention | Clopidogrel Dosage

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3539076
    UMLS CUI [1,2]
    C0184661
    UMLS CUI [2,1]
    C0070166
    UMLS CUI [2,2]
    C0178602
    3. informed, written consent by the patient or her/his legally-authorized representative for participation in the study.
    Description

    Informed Consent | Informed Consent Patient Representative

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C0030701
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. recent st-elevation myocardial infarction within the last 48 hours
    Description

    ST segment elevation myocardial infarction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1536220
    2. acute coronary syndromes with positive biomarkers (troponin t > 0.03 μg/l or ck-mb > uln)
    Description

    Acute Coronary Syndrome | Biological Markers Positive | Troponin T Assay | Creatine kinase MB measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0948089
    UMLS CUI [2,1]
    C0005516
    UMLS CUI [2,2]
    C1514241
    UMLS CUI [3]
    C1141947
    UMLS CUI [4]
    C0523584
    3. cardiogenic shock
    Description

    Shock, Cardiogenic

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0036980
    4. malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than one year or that may result in protocol non-compliance
    Description

    Malignant Neoplasms Protocol Compliance Lacking | Life Expectancy | Comorbidity Protocol Compliance Lacking | Liver disease Severe | Kidney Disease Severe | Pancreatic Disease Severe

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0525058
    UMLS CUI [1,3]
    C0332268
    UMLS CUI [2]
    C0023671
    UMLS CUI [3,1]
    C0009488
    UMLS CUI [3,2]
    C0525058
    UMLS CUI [3,3]
    C0332268
    UMLS CUI [4,1]
    C0023895
    UMLS CUI [4,2]
    C0205082
    UMLS CUI [5,1]
    C0022658
    UMLS CUI [5,2]
    C0205082
    UMLS CUI [6,1]
    C0030286
    UMLS CUI [6,2]
    C0205082
    5. active bleeding; bleeding diathesis
    Description

    Hemorrhage | Bleeding tendency

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019080
    UMLS CUI [2]
    C1458140
    6. history of gastrointestinal or genitourinary bleeding within the last 6 weeks
    Description

    Gastrointestinal Hemorrhage | Genitourinary tract hemorrhage

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0017181
    UMLS CUI [2]
    C0919591
    7. presence of diseases which have a high probability of vascular lesions and subsequent bleeding such as active gastric ulcer or active ulcerous colitis
    Description

    Disease Probability High Vascular lesions | Disease Probability High Hemorrhage | Gastric ulcer | Ulcerative Colitis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0033204
    UMLS CUI [1,3]
    C0205250
    UMLS CUI [1,4]
    C1402315
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C0033204
    UMLS CUI [2,3]
    C0205250
    UMLS CUI [2,4]
    C0019080
    UMLS CUI [3]
    C0038358
    UMLS CUI [4]
    C0009324
    8. recent trauma or major surgery in the last month
    Description

    Trauma | Major surgery

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3714660
    UMLS CUI [2]
    C0679637
    9. ophthalmic surgery or brain surgery in the last month
    Description

    Ophthalmologic Surgical Procedures | Operation on brain

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038901
    UMLS CUI [2]
    C0195775
    10. retinopathies or vitreous body bleeding in the last month
    Description

    Retinal Diseases | Vitreous Hemorrhage

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0035309
    UMLS CUI [2]
    C0042909
    11. history of intracranial bleeding or structural abnormalities (for example aneurysm of cerebral arteries)
    Description

    Intracranial Hemorrhage | Abnormality structural | Cerebral arterial aneurysm

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0151699
    UMLS CUI [2,1]
    C1704258
    UMLS CUI [2,2]
    C0678594
    UMLS CUI [3]
    C1290398
    12. suspected aortic dissection; pericarditis and subacute bacterial endocarditis
    Description

    Dissection of aorta Suspected | Pericarditis | Subacute Bacterial Endocarditis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0340643
    UMLS CUI [1,2]
    C0750491
    UMLS CUI [2]
    C0031046
    UMLS CUI [3]
    C0014122
    13. patient's refusal to blood transfusion.
    Description

    Blood Transfusion Refused

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005841
    UMLS CUI [1,2]
    C1705116
    14. oral anticoagulation therapy with coumarin derivative within the last 7 days
    Description

    Anticoagulation Therapy Oral | Coumadin Derivative

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003281
    UMLS CUI [1,2]
    C1527415
    UMLS CUI [2,1]
    C0699129
    UMLS CUI [2,2]
    C1527240
    15. treatment with ufh within 6 hours unless an act is less than 150 sec or low-molecular weight heparin within 8 hours before enrollment
    Description

    Unfractionated Heparin | Exception Activated clotting time measurement | Heparin, Low-Molecular-Weight

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2825026
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0427611
    UMLS CUI [3]
    C0019139
    16. treatment with bivalirudin within 24 hours before enrollment
    Description

    bivalirudin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0168273
    17. severe uncontrolled hypertension >180/110 mmhg unresponsive to therapy
    Description

    Uncontrolled hypertension Severe Unresponsive to Treatment

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1868885
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C0205269
    18. planned staged pci procedure within 30 days from index procedure or prior pci within the last 30 days.
    Description

    Staged Percutaneous Coronary Intervention Planned | Percutaneous Coronary Intervention Recent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3272260
    UMLS CUI [1,2]
    C1301732
    UMLS CUI [2,1]
    C1532338
    UMLS CUI [2,2]
    C0332185
    19. relevant hematologic deviations: hemoglobin < 100 g/l, platelet count < 100 x 109 /l.
    Description

    Hematology finding abnormal | Hemoglobin measurement | Platelet Count measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0475182
    UMLS CUI [2]
    C0518015
    UMLS CUI [3]
    C0032181
    20. glomerular filtration rate (gfr) < 30 ml/min or serum creatinine > 30 mg/l or dependence on renal dialysis.
    Description

    Glomerular Filtration Rate | Creatinine measurement, serum | Dependence on renal dialysis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0017654
    UMLS CUI [2]
    C0201976
    UMLS CUI [3]
    C0524376
    21. known allergy to the study medications: aspirin, clopidogrel, ufh, true anaphylaxis after prior exposure to contrast media.
    Description

    Hypersensitivity Investigational New Drugs | Aspirin allergy | Hypersensitivity Clopidogrel | Hypersensitivity Unfractionated Heparin | Anaphylaxis Post Exposure to Contrast Media

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [2]
    C0004058
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0070166
    UMLS CUI [4,1]
    C0020517
    UMLS CUI [4,2]
    C2825026
    UMLS CUI [5,1]
    C0002792
    UMLS CUI [5,2]
    C0687676
    UMLS CUI [5,3]
    C0332157
    UMLS CUI [5,4]
    C0009924
    22. known heparin-induced thrombocytopenia (typ ii)
    Description

    Heparin-induced thrombocytopenia type II

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0272275
    23. previous enrollment in this trial.
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    24. pregnancy (present, suspected or planned) or positive pregnancy test.
    Description

    Pregnancy | Pregnancy Suspected | Pregnancy, Planned | Pregnancy test positive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2,1]
    C0032961
    UMLS CUI [2,2]
    C0750491
    UMLS CUI [3]
    C0032992
    UMLS CUI [4]
    C0240802
    25. spinal, peridural and epidural anesthesia
    Description

    Spinal Anesthesia | Peridural Anesthesia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0002928
    UMLS CUI [2]
    C0002913
    26. patient's inability to fully cooperate with the study protocol.
    Description

    Protocol Compliance Unable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C1299582
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    Eligibility Coronary Artery Disease NCT00735280

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age | Percutaneous Coronary Intervention
    Item
    1. patients older than 18 years undergoing a pci procedure
    boolean
    C0001779 (UMLS CUI [1])
    C1532338 (UMLS CUI [2])
    Pretreatment Intervention | Clopidogrel Dosage
    Item
    2. pretreatment with 600mg clopidogrel at least 2 hours before the intervention
    boolean
    C3539076 (UMLS CUI [1,1])
    C0184661 (UMLS CUI [1,2])
    C0070166 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
    Informed Consent | Informed Consent Patient Representative
    Item
    3. informed, written consent by the patient or her/his legally-authorized representative for participation in the study.
    boolean
    C0021430 (UMLS CUI [1])
    C0021430 (UMLS CUI [2,1])
    C0030701 (UMLS CUI [2,2])
    Item Group
    C0680251 (UMLS CUI)
    ST segment elevation myocardial infarction
    Item
    1. recent st-elevation myocardial infarction within the last 48 hours
    boolean
    C1536220 (UMLS CUI [1])
    Acute Coronary Syndrome | Biological Markers Positive | Troponin T Assay | Creatine kinase MB measurement
    Item
    2. acute coronary syndromes with positive biomarkers (troponin t > 0.03 μg/l or ck-mb > uln)
    boolean
    C0948089 (UMLS CUI [1])
    C0005516 (UMLS CUI [2,1])
    C1514241 (UMLS CUI [2,2])
    C1141947 (UMLS CUI [3])
    C0523584 (UMLS CUI [4])
    Shock, Cardiogenic
    Item
    3. cardiogenic shock
    boolean
    C0036980 (UMLS CUI [1])
    Malignant Neoplasms Protocol Compliance Lacking | Life Expectancy | Comorbidity Protocol Compliance Lacking | Liver disease Severe | Kidney Disease Severe | Pancreatic Disease Severe
    Item
    4. malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than one year or that may result in protocol non-compliance
    boolean
    C0006826 (UMLS CUI [1,1])
    C0525058 (UMLS CUI [1,2])
    C0332268 (UMLS CUI [1,3])
    C0023671 (UMLS CUI [2])
    C0009488 (UMLS CUI [3,1])
    C0525058 (UMLS CUI [3,2])
    C0332268 (UMLS CUI [3,3])
    C0023895 (UMLS CUI [4,1])
    C0205082 (UMLS CUI [4,2])
    C0022658 (UMLS CUI [5,1])
    C0205082 (UMLS CUI [5,2])
    C0030286 (UMLS CUI [6,1])
    C0205082 (UMLS CUI [6,2])
    Hemorrhage | Bleeding tendency
    Item
    5. active bleeding; bleeding diathesis
    boolean
    C0019080 (UMLS CUI [1])
    C1458140 (UMLS CUI [2])
    Gastrointestinal Hemorrhage | Genitourinary tract hemorrhage
    Item
    6. history of gastrointestinal or genitourinary bleeding within the last 6 weeks
    boolean
    C0017181 (UMLS CUI [1])
    C0919591 (UMLS CUI [2])
    Disease Probability High Vascular lesions | Disease Probability High Hemorrhage | Gastric ulcer | Ulcerative Colitis
    Item
    7. presence of diseases which have a high probability of vascular lesions and subsequent bleeding such as active gastric ulcer or active ulcerous colitis
    boolean
    C0012634 (UMLS CUI [1,1])
    C0033204 (UMLS CUI [1,2])
    C0205250 (UMLS CUI [1,3])
    C1402315 (UMLS CUI [1,4])
    C0012634 (UMLS CUI [2,1])
    C0033204 (UMLS CUI [2,2])
    C0205250 (UMLS CUI [2,3])
    C0019080 (UMLS CUI [2,4])
    C0038358 (UMLS CUI [3])
    C0009324 (UMLS CUI [4])
    Trauma | Major surgery
    Item
    8. recent trauma or major surgery in the last month
    boolean
    C3714660 (UMLS CUI [1])
    C0679637 (UMLS CUI [2])
    Ophthalmologic Surgical Procedures | Operation on brain
    Item
    9. ophthalmic surgery or brain surgery in the last month
    boolean
    C0038901 (UMLS CUI [1])
    C0195775 (UMLS CUI [2])
    Retinal Diseases | Vitreous Hemorrhage
    Item
    10. retinopathies or vitreous body bleeding in the last month
    boolean
    C0035309 (UMLS CUI [1])
    C0042909 (UMLS CUI [2])
    Intracranial Hemorrhage | Abnormality structural | Cerebral arterial aneurysm
    Item
    11. history of intracranial bleeding or structural abnormalities (for example aneurysm of cerebral arteries)
    boolean
    C0151699 (UMLS CUI [1])
    C1704258 (UMLS CUI [2,1])
    C0678594 (UMLS CUI [2,2])
    C1290398 (UMLS CUI [3])
    Dissection of aorta Suspected | Pericarditis | Subacute Bacterial Endocarditis
    Item
    12. suspected aortic dissection; pericarditis and subacute bacterial endocarditis
    boolean
    C0340643 (UMLS CUI [1,1])
    C0750491 (UMLS CUI [1,2])
    C0031046 (UMLS CUI [2])
    C0014122 (UMLS CUI [3])
    Blood Transfusion Refused
    Item
    13. patient's refusal to blood transfusion.
    boolean
    C0005841 (UMLS CUI [1,1])
    C1705116 (UMLS CUI [1,2])
    Anticoagulation Therapy Oral | Coumadin Derivative
    Item
    14. oral anticoagulation therapy with coumarin derivative within the last 7 days
    boolean
    C0003281 (UMLS CUI [1,1])
    C1527415 (UMLS CUI [1,2])
    C0699129 (UMLS CUI [2,1])
    C1527240 (UMLS CUI [2,2])
    Unfractionated Heparin | Exception Activated clotting time measurement | Heparin, Low-Molecular-Weight
    Item
    15. treatment with ufh within 6 hours unless an act is less than 150 sec or low-molecular weight heparin within 8 hours before enrollment
    boolean
    C2825026 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0427611 (UMLS CUI [2,2])
    C0019139 (UMLS CUI [3])
    bivalirudin
    Item
    16. treatment with bivalirudin within 24 hours before enrollment
    boolean
    C0168273 (UMLS CUI [1])
    Uncontrolled hypertension Severe Unresponsive to Treatment
    Item
    17. severe uncontrolled hypertension >180/110 mmhg unresponsive to therapy
    boolean
    C1868885 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0205269 (UMLS CUI [1,3])
    Staged Percutaneous Coronary Intervention Planned | Percutaneous Coronary Intervention Recent
    Item
    18. planned staged pci procedure within 30 days from index procedure or prior pci within the last 30 days.
    boolean
    C3272260 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    C1532338 (UMLS CUI [2,1])
    C0332185 (UMLS CUI [2,2])
    Hematology finding abnormal | Hemoglobin measurement | Platelet Count measurement
    Item
    19. relevant hematologic deviations: hemoglobin < 100 g/l, platelet count < 100 x 109 /l.
    boolean
    C0475182 (UMLS CUI [1])
    C0518015 (UMLS CUI [2])
    C0032181 (UMLS CUI [3])
    Glomerular Filtration Rate | Creatinine measurement, serum | Dependence on renal dialysis
    Item
    20. glomerular filtration rate (gfr) < 30 ml/min or serum creatinine > 30 mg/l or dependence on renal dialysis.
    boolean
    C0017654 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    C0524376 (UMLS CUI [3])
    Hypersensitivity Investigational New Drugs | Aspirin allergy | Hypersensitivity Clopidogrel | Hypersensitivity Unfractionated Heparin | Anaphylaxis Post Exposure to Contrast Media
    Item
    21. known allergy to the study medications: aspirin, clopidogrel, ufh, true anaphylaxis after prior exposure to contrast media.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0004058 (UMLS CUI [2])
    C0020517 (UMLS CUI [3,1])
    C0070166 (UMLS CUI [3,2])
    C0020517 (UMLS CUI [4,1])
    C2825026 (UMLS CUI [4,2])
    C0002792 (UMLS CUI [5,1])
    C0687676 (UMLS CUI [5,2])
    C0332157 (UMLS CUI [5,3])
    C0009924 (UMLS CUI [5,4])
    Heparin-induced thrombocytopenia type II
    Item
    22. known heparin-induced thrombocytopenia (typ ii)
    boolean
    C0272275 (UMLS CUI [1])
    Study Subject Participation Status
    Item
    23. previous enrollment in this trial.
    boolean
    C2348568 (UMLS CUI [1])
    Pregnancy | Pregnancy Suspected | Pregnancy, Planned | Pregnancy test positive
    Item
    24. pregnancy (present, suspected or planned) or positive pregnancy test.
    boolean
    C0032961 (UMLS CUI [1])
    C0032961 (UMLS CUI [2,1])
    C0750491 (UMLS CUI [2,2])
    C0032992 (UMLS CUI [3])
    C0240802 (UMLS CUI [4])
    Spinal Anesthesia | Peridural Anesthesia
    Item
    25. spinal, peridural and epidural anesthesia
    boolean
    C0002928 (UMLS CUI [1])
    C0002913 (UMLS CUI [2])
    Protocol Compliance Unable
    Item
    26. patient's inability to fully cooperate with the study protocol.
    boolean
    C0525058 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
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