ID

11721

Beschreibung

The aim of the Mashed Or Just Integral pill of TicagrelOr (MOJITO) study is to evaluate the superiority of Ticagrelor 180 mg LD mashed pill versus Ticagrelor 180 mg LD integral pill both orally administrated in decreasing residual platelet reactivity 1 hour after the administration among 70 patients with STEMI (ST segment elevation myocardial infarction) undergoing PPCI (primary percutaneous coronary intervention) with bivalirudin monotherapy.

Stichworte

Versionen (2)
  1. 28.07.15 28.07.15 -
  2. 21.11.15 21.11.15 -
Hochgeladen am

28. Juli 2015

DOI

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Eligibility Criteria: Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? )

Englisch

Eligibility Criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Inclusion Criteria
Beschreibung

Inclusion Criteria

Patients presenting within 12 hours from the onset of symptoms with STEMI
Beschreibung

Patients presenting within 12 hours from the onset of symptoms with STEMI

Datentyp

boolean

Alias
UMLS CUI-1
C1536220
Informed, written consent
Beschreibung

Informed, written consent

Datentyp

boolean

Exclusion Criteria
Beschreibung

Exclusion Criteria

Age < 18 years or Age > 75 years
Beschreibung

Age < 18 years or Age > 75 years

Datentyp

boolean

Alias
UMLS CUI-1
C0001779
Active bleeding
Beschreibung

Active bleeding

Datentyp

boolean

Alias
UMLS CUI-1
C0019080
bleeding diathesis
Beschreibung

bleeding diathesis

Datentyp

boolean

Alias
UMLS CUI-1
C3251812
coagulopathy
Beschreibung

coagulopathy

Datentyp

boolean

Alias
UMLS CUI-1
C0005779
Increased risk of bradycardiac events
Beschreibung

Increased risk of bradycardiac events

Datentyp

boolean

Alias
UMLS CUI-1
C0428977
History of gastrointestinal bleeding <2 months
Beschreibung

History of gastrointestinal bleeding <2 months

Datentyp

boolean

Alias
UMLS CUI-1
C0017181
History of genitourinary bleeding <2 months
Beschreibung

History of genitourinary bleeding <2 months

Datentyp

boolean

Alias
UMLS CUI-1
C0919591
Major surgery in the last 6 weeks
Beschreibung

Major surgery in the last 6 weeks

Datentyp

boolean

Alias
UMLS CUI-1
C0679637
History of intracranial bleeding or structural abnormalities
Beschreibung

History of intracranial bleeding or structural abnormalities

Datentyp

boolean

Alias
UMLS CUI-1
C0151699
Suspected aortic dissection
Beschreibung

Suspected aortic dissection

Datentyp

boolean

Alias
UMLS CUI-1
C0340643
Administration in the week before the index event of clopidogrel
Beschreibung

Administration in the week before the index event of clopidogrel

Datentyp

boolean

Alias
UMLS CUI-1
C0070166
Administration in the week before the index event of ticlopidine
Beschreibung

Administration in the week before the index event of ticlopidine

Datentyp

boolean

Alias
UMLS CUI-1
C0040207
Administration in the week before the index event of prasugrel
Beschreibung

Administration in the week before the index event of prasugrel

Datentyp

boolean

Alias
UMLS CUI-1
C1620287
Administration in the week before the index event of ticagrelor
Beschreibung

Administration in the week before the index event of ticagrelor

Datentyp

boolean

Alias
UMLS CUI-1
C1999375
Administration in the week before the index event of thrombolytics
Beschreibung

Administration in the week before the index event of thrombolytics

Datentyp

boolean

Alias
UMLS CUI-1
C0040044
Administration in the week before the index event of bivalirudin
Beschreibung

Administration in the week before the index event of bivalirudin

Datentyp

boolean

Alias
UMLS CUI-1
C0168273
Administration in the week before the index event of low-molecular weight heparin
Beschreibung

Administration in the week before the index event of low-molecular weight heparin

Datentyp

boolean

Alias
UMLS CUI-1
C3536766
Administration in the week before the index event of fondaparinux
Beschreibung

Administration in the week before the index event of fondaparinux

Datentyp

boolean

Alias
UMLS CUI-1
C1098510
Concomitant oral or IV therapy with strong CYP3A inhibitors
Beschreibung

Concomitant oral or IV therapy with strong CYP3A inhibitors

Datentyp

boolean

Alias
UMLS CUI-1
C3830624
Concomitant oral or IV therapy with strong CYP3A inducers
Beschreibung

Concomitant oral or IV therapy with strong CYP3A inducers

Datentyp

boolean

Alias
UMLS CUI-1
C3830625
Known relevant hematological deviations: Hb <10 g/dl
Beschreibung

Known relevant hematological deviations: Hb <10 g/dl

Datentyp

boolean

Alias
UMLS CUI-1
C0518015
Known relevant hematological deviations: Thrombi. <100x10^9/l
Beschreibung

Known relevant hematological deviations: Thrombi. <100x10^9/l

Datentyp

boolean

Alias
UMLS CUI-1
C0032181
Use of coumadin derivatives within the last 7 days
Beschreibung

Use of coumadin derivatives within the last 7 days

Datentyp

boolean

Alias
UMLS CUI-1
C0043031
Known severe liver disease
Beschreibung

Known severe liver disease

Datentyp

boolean

Alias
UMLS CUI-1
C0085605
severe renal failure
Beschreibung

severe renal failure

Datentyp

boolean

Alias
UMLS CUI-1
C0035078
Known allergy to the study medications
Beschreibung

Known allergy to the study medications

Datentyp

boolean

Alias
UMLS CUI-1
C0013182
Pregnancy
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI-1
C0549206
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Ähnliche Modelle

Eligibility Criteria

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
STEMI
Item
Patients presenting within 12 hours from the onset of symptoms with STEMI
boolean
C1536220 (UMLS CUI-1)
Informed consent
Item
Informed, written consent
boolean
Item Group
Exclusion Criteria
Age
Item
Age < 18 years or Age > 75 years
boolean
C0001779 (UMLS CUI-1)
Hemorrhage
Item
Active bleeding
boolean
C0019080 (UMLS CUI-1)
Bleeding risk
Item
bleeding diathesis
boolean
C3251812 (UMLS CUI-1)
Coagulopathy
Item
coagulopathy
boolean
C0005779 (UMLS CUI-1)
Bradycardia
Item
Increased risk of bradycardiac events
boolean
C0428977 (UMLS CUI-1)
Gastrointestinal Hemorrhage
Item
History of gastrointestinal bleeding <2 months
boolean
C0017181 (UMLS CUI-1)
Genitourinary tract hemorrhage
Item
History of genitourinary bleeding <2 months
boolean
C0919591 (UMLS CUI-1)
Major surgery
Item
Major surgery in the last 6 weeks
boolean
C0679637 (UMLS CUI-1)
Intracranial hemorrhage
Item
History of intracranial bleeding or structural abnormalities
boolean
C0151699 (UMLS CUI-1)
Aortic dissection
Item
Suspected aortic dissection
boolean
C0340643 (UMLS CUI-1)
Clopidogrel
Item
Administration in the week before the index event of clopidogrel
boolean
C0070166 (UMLS CUI-1)
Ticlopidine
Item
Administration in the week before the index event of ticlopidine
boolean
C0040207 (UMLS CUI-1)
Prasugrel
Item
Administration in the week before the index event of prasugrel
boolean
C1620287 (UMLS CUI-1)
Ticagrelor
Item
Administration in the week before the index event of ticagrelor
boolean
C1999375 (UMLS CUI-1)
Thrombolytic therapy
Item
Administration in the week before the index event of thrombolytics
boolean
C0040044 (UMLS CUI-1)
Bivalirudin
Item
Administration in the week before the index event of bivalirudin
boolean
C0168273 (UMLS CUI-1)
LMWH
Item
Administration in the week before the index event of low-molecular weight heparin
boolean
C3536766 (UMLS CUI-1)
Fondaparinux
Item
Administration in the week before the index event of fondaparinux
boolean
C1098510 (UMLS CUI-1)
Cytochrome P450 3A4 Inhibitor
Item
Concomitant oral or IV therapy with strong CYP3A inhibitors
boolean
C3830624 (UMLS CUI-1)
Cytochrome P450 3A4 Inducer
Item
Concomitant oral or IV therapy with strong CYP3A inducers
boolean
C3830625 (UMLS CUI-1)
Hemoglobin measurement
Item
Known relevant hematological deviations: Hb <10 g/dl
boolean
C0518015 (UMLS CUI-1)
Platelet count
Item
Known relevant hematological deviations: Thrombi. <100x10^9/l
boolean
C0032181 (UMLS CUI-1)
Warfarin
Item
Use of coumadin derivatives within the last 7 days
boolean
C0043031 (UMLS CUI-1)
Liver failure
Item
Known severe liver disease
boolean
C0085605 (UMLS CUI-1)
Kidney failure
Item
severe renal failure
boolean
C0035078 (UMLS CUI-1)
Medication allergy
Item
Known allergy to the study medications
boolean
C0013182 (UMLS CUI-1)
Pregnancy
Item
Pregnancy
boolean
C0549206 (UMLS CUI-1)
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