ID

28481

Descripción

Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents; ODM derived from: https://clinicaltrials.gov/show/NCT00638794

Link

https://clinicaltrials.gov/show/NCT00638794

Palabras clave

Versiones (1)
  1. 17/1/18 17/1/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

17 de enero de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00638794

Inglés

Eligibility Coronary Artery Disease NCT00638794

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients undergoing pci in whom at least one des is implanted and in whom pci of all treated lesions is successful (diameter stenosis <30% with timi 3 flow in all treated lesions) without major complications (defined as freedom from procedural death, intra-procedural stent thrombosis, procedural myocardial infarction or sustained vessel closure, or need for emergency bypass graft surgery). one or more bare metal stents (bms) may be implanted, and other lesions may be treated without stenting as long as at least one des is implanted. however, the procedure must be successful and uncomplicated (as defined above) for all lesions (des + bms + non-stent).
Descripción

Percutaneous Coronary Intervention | Implantation Drug-Eluting Stents Quantity | Percent Diameter Stenosis Measurement | Lesion Treated Thrombolysis in Myocardial Infarction Flow | Complication Major Absent | Cessation of life Free of | Stent thrombosis Free of | Myocardial Infarction Free of | Vessel Closure Sustained Free of | Emergency CABG Free of | Implantation Bare metal stent Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2,1]
C0021107
UMLS CUI [2,2]
C1322815
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C3897965
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C1522326
UMLS CUI [4,3]
C3272266
UMLS CUI [5,1]
C0009566
UMLS CUI [5,2]
C0205164
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C0011065
UMLS CUI [6,2]
C0332296
UMLS CUI [7,1]
C3897493
UMLS CUI [7,2]
C0332296
UMLS CUI [8,1]
C0027051
UMLS CUI [8,2]
C0332296
UMLS CUI [9,1]
C0005847
UMLS CUI [9,2]
C0185003
UMLS CUI [9,3]
C0443318
UMLS CUI [9,4]
C0332296
UMLS CUI [10,1]
C1532296
UMLS CUI [10,2]
C0332296
UMLS CUI [11,1]
C0021107
UMLS CUI [11,2]
C2825200
UMLS CUI [11,3]
C1265611
2. aspirin use: adequate aspirin loading given prior to pci: at least 300 mg non enteric coated oral aspirin at least 1 hour prior to the procedure or 324 mg chewed or 250 mg iv aspirin at least 30 minutes prior to the procedure.
Descripción

Aspirin | Percutaneous Coronary Intervention Status pre- | Aspirin Oral Product Dosage | Aspirin Chewable Tablet Dosage | Aspirin Intravenous Dosage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004057
UMLS CUI [2,1]
C1532338
UMLS CUI [2,2]
C0332152
UMLS CUI [3,1]
C0732305
UMLS CUI [3,2]
C0178602
UMLS CUI [4,1]
C0004057
UMLS CUI [4,2]
C0304290
UMLS CUI [4,3]
C0178602
UMLS CUI [5,1]
C0004057
UMLS CUI [5,2]
C1522726
UMLS CUI [5,3]
C0178602
3. patient has hematocrit between 30 and 52% and platelet count greater than 100,000/µl.
Descripción

Hematocrit level | Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518014
UMLS CUI [2]
C0032181
4. for us sites: only fda-approved des stents may be used in this study. for ous sites: only des stents that are ce marked for approval may be used in this study.
Descripción

Drug-Eluting Stents Restriction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1322815
UMLS CUI [1,2]
C0443288
5. pci performed with unfractionated or low molecular weight heparin, or bivalirudin as the procedural antithrombin.
Descripción

Percutaneous Coronary Intervention | Unfractionated Heparin | Heparin, Low-Molecular-Weight | bivalirudin | Antithrombin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2]
C2825026
UMLS CUI [3]
C0019139
UMLS CUI [4]
C0168273
UMLS CUI [5]
C0003440
6. patient or guardian able to provide informed written consent.
Descripción

Informed Consent | Informed Consent Guardian

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients in whom blood for accumetrics verifynow platelet function testing cannot be drawn after the minimum clopidogrel loading duration and glycoprotein (gp) iib/iiia inhibitor washout duration as follows:
Descripción

Blood draw Unsuccessful Platelet Function Tests | Clopidogrel | Glycoprotein IIb/IIIa Antagonist Washout Period

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1272705
UMLS CUI [1,3]
C0032184
UMLS CUI [2]
C0070166
UMLS CUI [3,1]
C3640054
UMLS CUI [3,2]
C1710661
1. clopidogrel loading: clopidogrel loading pre pci is recommended, but post pci clopidogrel loading is acceptable per standard of care. in all patients (whether or not clopidogrel is initiated pre or post pci), prior to blood drawing for verifynow platelet function testing, a 600 mg loading dose must have been given at least 6 hours prior, or a 300 mg loading dose must have been given at least 12 hours prior, or the patient must have been maintained on at least 75 mg of clopidogrel daily for at least 5 days.
Descripción

Clopidogrel | Percutaneous Coronary Intervention Status pre- | Percutaneous Coronary Intervention Status post | Blood draw Platelet Function Tests | Clopidogrel Loading dose

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0070166
UMLS CUI [2,1]
C1532338
UMLS CUI [2,2]
C0332152
UMLS CUI [3,1]
C1532338
UMLS CUI [3,2]
C0231290
UMLS CUI [4,1]
C0005834
UMLS CUI [4,2]
C0032184
UMLS CUI [5,1]
C0070166
UMLS CUI [5,2]
C3714444
2. gp iib/iiia inhibitor washout: eptifibatide or tirofiban must have been discontinued for at least 24 hours prior to verifynow platelet function testing. abciximab must have been discontinued for at 10 days prior to verifynow platelet function testing.
Descripción

Glycoprotein IIb/IIIa Antagonist Washout | Eptifibatide To be stopped | Tirofiban To be stopped | Platelet Function Tests | Abciximab To be stopped

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3640054
UMLS CUI [1,2]
C1710661
UMLS CUI [2,1]
C0253563
UMLS CUI [2,2]
C1272691
UMLS CUI [3,1]
C0247025
UMLS CUI [3,2]
C1272691
UMLS CUI [4]
C0032184
UMLS CUI [5,1]
C0288672
UMLS CUI [5,2]
C1272691
2. inability of the verifynow system to measure either aspirin, p2y12 or iib/iiia platelet responsiveness.
Descripción

Platelet Function Test Other Coding | Aspirin Responsiveness assessment Unable | P2Y12 Responsiveness assessment Unable | Platelet Glycoprotein GPIIb-IIIa Complex Responsiveness assessment Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032184
UMLS CUI [1,2]
C3846158
UMLS CUI [2,1]
C0004057
UMLS CUI [2,2]
C0552602
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C1425330
UMLS CUI [3,2]
C0552602
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0016011
UMLS CUI [4,2]
C0552602
UMLS CUI [4,3]
C1299582
3. severe allergy to stainless steel, contrast dye, all anti-thrombin agents (unfractionated and low molecular weight heparin and bivalirudin), aspirin or clopidogrel that cannot be adequately pre-medicated.
Descripción

Severe allergy Stainless Steel | Contrast dye allergy Severe | Severe allergy Antithrombins | Severe allergy Unfractionated Heparin | Severe allergy Low-Molecular-Weight Heparin | Severe allergy bivalirudin | Aspirin allergy Severe | Severe allergy clopidogrel | Premedication Unsuccessful

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0038126
UMLS CUI [2,1]
C0742797
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C2945656
UMLS CUI [3,2]
C0003440
UMLS CUI [4,1]
C2945656
UMLS CUI [4,2]
C2825026
UMLS CUI [5,1]
C2945656
UMLS CUI [5,2]
C0019139
UMLS CUI [6,1]
C2945656
UMLS CUI [6,2]
C0168273
UMLS CUI [7,1]
C0004058
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C2945656
UMLS CUI [8,2]
C0070166
UMLS CUI [9,1]
C0033045
UMLS CUI [9,2]
C1272705
4. concurrent enrollment in another trial that involves an investigational stent, antithrombotic or antiplatelet agent. patient in other investigational trials that have not reached their primary endpoint may be enrolled in adapt-des as long as the other trials do not involve an investigational stent, antithrombotic or antiplatelet agent and inclusion of such patient will have no effect on the endpoint of either study.
Descripción

Study Subject Participation Status | Stent Investigational | Antithrombotic Agents | Antiplatelet Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0038257
UMLS CUI [2,2]
C1517586
UMLS CUI [3]
C1704311
UMLS CUI [4]
C0085826
5. patients in whom bypass graft surgery is planned within 2 years.
Descripción

Coronary Artery Bypass Surgery Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C1301732
6. patients with stent thrombosis before the performance of pre-discharge verifynow platelet function testing.
Descripción

Stent thrombosis Before Platelet Function Tests

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3897493
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0032184
7. patients unwilling or unable to complete clinical follow-up for the duration of the study.
Descripción

Follow-up Completion Unwilling | Follow-up Completion Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C1299582
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Similar models

Eligibility Coronary Artery Disease NCT00638794

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Percutaneous Coronary Intervention | Implantation Drug-Eluting Stents Quantity | Percent Diameter Stenosis Measurement | Lesion Treated Thrombolysis in Myocardial Infarction Flow | Complication Major Absent | Cessation of life Free of | Stent thrombosis Free of | Myocardial Infarction Free of | Vessel Closure Sustained Free of | Emergency CABG Free of | Implantation Bare metal stent Quantity
Item
1. patients undergoing pci in whom at least one des is implanted and in whom pci of all treated lesions is successful (diameter stenosis <30% with timi 3 flow in all treated lesions) without major complications (defined as freedom from procedural death, intra-procedural stent thrombosis, procedural myocardial infarction or sustained vessel closure, or need for emergency bypass graft surgery). one or more bare metal stents (bms) may be implanted, and other lesions may be treated without stenting as long as at least one des is implanted. however, the procedure must be successful and uncomplicated (as defined above) for all lesions (des + bms + non-stent).
boolean
C1532338 (UMLS CUI [1])
C0021107 (UMLS CUI [2,1])
C1322815 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C3897965 (UMLS CUI [3])
C0221198 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C3272266 (UMLS CUI [4,3])
C0009566 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0011065 (UMLS CUI [6,1])
C0332296 (UMLS CUI [6,2])
C3897493 (UMLS CUI [7,1])
C0332296 (UMLS CUI [7,2])
C0027051 (UMLS CUI [8,1])
C0332296 (UMLS CUI [8,2])
C0005847 (UMLS CUI [9,1])
C0185003 (UMLS CUI [9,2])
C0443318 (UMLS CUI [9,3])
C0332296 (UMLS CUI [9,4])
C1532296 (UMLS CUI [10,1])
C0332296 (UMLS CUI [10,2])
C0021107 (UMLS CUI [11,1])
C2825200 (UMLS CUI [11,2])
C1265611 (UMLS CUI [11,3])
Aspirin | Percutaneous Coronary Intervention Status pre- | Aspirin Oral Product Dosage | Aspirin Chewable Tablet Dosage | Aspirin Intravenous Dosage
Item
2. aspirin use: adequate aspirin loading given prior to pci: at least 300 mg non enteric coated oral aspirin at least 1 hour prior to the procedure or 324 mg chewed or 250 mg iv aspirin at least 30 minutes prior to the procedure.
boolean
C0004057 (UMLS CUI [1])
C1532338 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0732305 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0004057 (UMLS CUI [4,1])
C0304290 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0004057 (UMLS CUI [5,1])
C1522726 (UMLS CUI [5,2])
C0178602 (UMLS CUI [5,3])
Hematocrit level | Platelet Count measurement
Item
3. patient has hematocrit between 30 and 52% and platelet count greater than 100,000/µl.
boolean
C0518014 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Drug-Eluting Stents Restriction
Item
4. for us sites: only fda-approved des stents may be used in this study. for ous sites: only des stents that are ce marked for approval may be used in this study.
boolean
C1322815 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
Percutaneous Coronary Intervention | Unfractionated Heparin | Heparin, Low-Molecular-Weight | bivalirudin | Antithrombin
Item
5. pci performed with unfractionated or low molecular weight heparin, or bivalirudin as the procedural antithrombin.
boolean
C1532338 (UMLS CUI [1])
C2825026 (UMLS CUI [2])
C0019139 (UMLS CUI [3])
C0168273 (UMLS CUI [4])
C0003440 (UMLS CUI [5])
Informed Consent | Informed Consent Guardian
Item
6. patient or guardian able to provide informed written consent.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Blood draw Unsuccessful Platelet Function Tests | Clopidogrel | Glycoprotein IIb/IIIa Antagonist Washout Period
Item
1. patients in whom blood for accumetrics verifynow platelet function testing cannot be drawn after the minimum clopidogrel loading duration and glycoprotein (gp) iib/iiia inhibitor washout duration as follows:
boolean
C0005834 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C0032184 (UMLS CUI [1,3])
C0070166 (UMLS CUI [2])
C3640054 (UMLS CUI [3,1])
C1710661 (UMLS CUI [3,2])
Clopidogrel | Percutaneous Coronary Intervention Status pre- | Percutaneous Coronary Intervention Status post | Blood draw Platelet Function Tests | Clopidogrel Loading dose
Item
1. clopidogrel loading: clopidogrel loading pre pci is recommended, but post pci clopidogrel loading is acceptable per standard of care. in all patients (whether or not clopidogrel is initiated pre or post pci), prior to blood drawing for verifynow platelet function testing, a 600 mg loading dose must have been given at least 6 hours prior, or a 300 mg loading dose must have been given at least 12 hours prior, or the patient must have been maintained on at least 75 mg of clopidogrel daily for at least 5 days.
boolean
C0070166 (UMLS CUI [1])
C1532338 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C1532338 (UMLS CUI [3,1])
C0231290 (UMLS CUI [3,2])
C0005834 (UMLS CUI [4,1])
C0032184 (UMLS CUI [4,2])
C0070166 (UMLS CUI [5,1])
C3714444 (UMLS CUI [5,2])
Glycoprotein IIb/IIIa Antagonist Washout | Eptifibatide To be stopped | Tirofiban To be stopped | Platelet Function Tests | Abciximab To be stopped
Item
2. gp iib/iiia inhibitor washout: eptifibatide or tirofiban must have been discontinued for at least 24 hours prior to verifynow platelet function testing. abciximab must have been discontinued for at 10 days prior to verifynow platelet function testing.
boolean
C3640054 (UMLS CUI [1,1])
C1710661 (UMLS CUI [1,2])
C0253563 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0247025 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
C0032184 (UMLS CUI [4])
C0288672 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
Platelet Function Test Other Coding | Aspirin Responsiveness assessment Unable | P2Y12 Responsiveness assessment Unable | Platelet Glycoprotein GPIIb-IIIa Complex Responsiveness assessment Unable
Item
2. inability of the verifynow system to measure either aspirin, p2y12 or iib/iiia platelet responsiveness.
boolean
C0032184 (UMLS CUI [1,1])
C3846158 (UMLS CUI [1,2])
C0004057 (UMLS CUI [2,1])
C0552602 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C1425330 (UMLS CUI [3,1])
C0552602 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0016011 (UMLS CUI [4,1])
C0552602 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
Severe allergy Stainless Steel | Contrast dye allergy Severe | Severe allergy Antithrombins | Severe allergy Unfractionated Heparin | Severe allergy Low-Molecular-Weight Heparin | Severe allergy bivalirudin | Aspirin allergy Severe | Severe allergy clopidogrel | Premedication Unsuccessful
Item
3. severe allergy to stainless steel, contrast dye, all anti-thrombin agents (unfractionated and low molecular weight heparin and bivalirudin), aspirin or clopidogrel that cannot be adequately pre-medicated.
boolean
C2945656 (UMLS CUI [1,1])
C0038126 (UMLS CUI [1,2])
C0742797 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2945656 (UMLS CUI [3,1])
C0003440 (UMLS CUI [3,2])
C2945656 (UMLS CUI [4,1])
C2825026 (UMLS CUI [4,2])
C2945656 (UMLS CUI [5,1])
C0019139 (UMLS CUI [5,2])
C2945656 (UMLS CUI [6,1])
C0168273 (UMLS CUI [6,2])
C0004058 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C2945656 (UMLS CUI [8,1])
C0070166 (UMLS CUI [8,2])
C0033045 (UMLS CUI [9,1])
C1272705 (UMLS CUI [9,2])
Study Subject Participation Status | Stent Investigational | Antithrombotic Agents | Antiplatelet Agents
Item
4. concurrent enrollment in another trial that involves an investigational stent, antithrombotic or antiplatelet agent. patient in other investigational trials that have not reached their primary endpoint may be enrolled in adapt-des as long as the other trials do not involve an investigational stent, antithrombotic or antiplatelet agent and inclusion of such patient will have no effect on the endpoint of either study.
boolean
C2348568 (UMLS CUI [1])
C0038257 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C1704311 (UMLS CUI [3])
C0085826 (UMLS CUI [4])
Coronary Artery Bypass Surgery Planned
Item
5. patients in whom bypass graft surgery is planned within 2 years.
boolean
C0010055 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Stent thrombosis Before Platelet Function Tests
Item
6. patients with stent thrombosis before the performance of pre-discharge verifynow platelet function testing.
boolean
C3897493 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0032184 (UMLS CUI [1,3])
Follow-up Completion Unwilling | Follow-up Completion Unable
Item
7. patients unwilling or unable to complete clinical follow-up for the duration of the study.
boolean
C3274571 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3274571 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
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