ID

37597

Description

Optimizing Antithrombotic Care in Patients With AtriaL fibrillatiON and Coronary stEnt (OAC-ALONE) Study; ODM derived from: https://clinicaltrials.gov/show/NCT01962545

Link

https://clinicaltrials.gov/show/NCT01962545

Keywords

Versions (1)
  1. 8/10/19 8/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 10, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01962545

English

Eligibility Atrial Fibrillation NCT01962545

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with a documented history of af who underwent pci with stenting >12 months before enrollment.
Description

Atrial Fibrillation | Percutaneous Coronary Intervention | Stenting

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C1532338
UMLS CUI [3]
C2348535
2. patients who are treated with oac (warfarin or noac) and an antiplatelet drug (aspirin or clopidogrel), but not with other antiplatelet drugs including ticlopidine, prasugrel, ticagrelor, and cilostazol.
Description

Oral anticoagulants | Warfarin | Oral anticoagulants New | Antiplatelet Agents | Aspirin | clopidogrel | Exception Ticlopidine | Exception Prasugrel | Exception Ticagrelor | Exception Cilostazol

Data type

boolean

Alias
UMLS CUI [1]
C0354604
UMLS CUI [2]
C0043031
UMLS CUI [3,1]
C0354604
UMLS CUI [3,2]
C0205314
UMLS CUI [4]
C0085826
UMLS CUI [5]
C0004057
UMLS CUI [6]
C0070166
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0040207
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C1620287
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C1999375
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0055729
3. in patients treated with warfarin, the inr value at enrollment should be => 1.6, and agreement on dose adjustment of warfarin with the target inr range of 2.0-3.0 for those <70 years and 1.6-2.6 for those =>70 years, which is recommended in the japanese guidelines, is necessary before enrollment.
Description

Warfarin | INR | Warfarin Dose Adjustment | INR Target Range | Age

Data type

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0525032
UMLS CUI [3,1]
C0043031
UMLS CUI [3,2]
C2826232
UMLS CUI [4,1]
C0525032
UMLS CUI [4,2]
C1521840
UMLS CUI [4,3]
C1514721
UMLS CUI [5]
C0001779
4. patients 20 years or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. patients with written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who underwent pci including balloon angioplasty alone within the past 12 months.
Description

Percutaneous Coronary Intervention Recently | Balloon Angioplasty Recently

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0002996
UMLS CUI [2,2]
C0332185
2. patients in whom oac is scheduled to be discontinued during the follow-up period.
Description

Oral anticoagulants To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C0354604
UMLS CUI [1,2]
C1272691
3. patients with a past history of st.
Description

Sinus Tachycardia In the past

Data type

boolean

Alias
UMLS CUI [1,1]
C0039239
UMLS CUI [1,2]
C1444637
4. patients with a planned coronary revascularization.
Description

Coronary revascularisation Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C1301732
5. patients with a planned cardiovascular or non-cardiovascular surgery.
Description

Cardiovascular Surgical Procedure Planned | Operative Surgical Procedure Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0038897
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1301732
6. patients with expectation of survival less than one year.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Atrial Fibrillation NCT01962545

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Atrial Fibrillation | Percutaneous Coronary Intervention | Stenting
Item
1. patients with a documented history of af who underwent pci with stenting >12 months before enrollment.
boolean
C0004238 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
C2348535 (UMLS CUI [3])
Oral anticoagulants | Warfarin | Oral anticoagulants New | Antiplatelet Agents | Aspirin | clopidogrel | Exception Ticlopidine | Exception Prasugrel | Exception Ticagrelor | Exception Cilostazol
Item
2. patients who are treated with oac (warfarin or noac) and an antiplatelet drug (aspirin or clopidogrel), but not with other antiplatelet drugs including ticlopidine, prasugrel, ticagrelor, and cilostazol.
boolean
C0354604 (UMLS CUI [1])
C0043031 (UMLS CUI [2])
C0354604 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
C0085826 (UMLS CUI [4])
C0004057 (UMLS CUI [5])
C0070166 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0040207 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C1620287 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C1999375 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C0055729 (UMLS CUI [10,2])
Warfarin | INR | Warfarin Dose Adjustment | INR Target Range | Age
Item
3. in patients treated with warfarin, the inr value at enrollment should be => 1.6, and agreement on dose adjustment of warfarin with the target inr range of 2.0-3.0 for those <70 years and 1.6-2.6 for those =>70 years, which is recommended in the japanese guidelines, is necessary before enrollment.
boolean
C0043031 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
C0043031 (UMLS CUI [3,1])
C2826232 (UMLS CUI [3,2])
C0525032 (UMLS CUI [4,1])
C1521840 (UMLS CUI [4,2])
C1514721 (UMLS CUI [4,3])
C0001779 (UMLS CUI [5])
Age
Item
4. patients 20 years or older.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
5. patients with written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Percutaneous Coronary Intervention Recently | Balloon Angioplasty Recently
Item
1. patients who underwent pci including balloon angioplasty alone within the past 12 months.
boolean
C1532338 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0002996 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Oral anticoagulants To be stopped
Item
2. patients in whom oac is scheduled to be discontinued during the follow-up period.
boolean
C0354604 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Sinus Tachycardia In the past
Item
3. patients with a past history of st.
boolean
C0039239 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
Coronary revascularisation Planned
Item
4. patients with a planned coronary revascularization.
boolean
C0877341 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Cardiovascular Surgical Procedure Planned | Operative Surgical Procedure Planned
Item
5. patients with a planned cardiovascular or non-cardiovascular surgery.
boolean
C0038897 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Life Expectancy
Item
6. patients with expectation of survival less than one year.
boolean
C0023671 (UMLS CUI [1])
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