ID

12467

Description

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. https://clinicaltrials.gov/ct2/show/NCT01992523

Link

https://clinicaltrials.gov/ct2/show/NCT01992523

Keywords

Versions (2)
  1. 7/28/15 7/28/15 -
  2. 11/21/15 11/21/15 -
Uploaded on

November 21, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Mojito Study Acute Coronary Syndrome NCT01992523

English

Eligibility Criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

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

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

Data type

boolean

Alias
UMLS CUI-1
C1536220
Informed, written consent
Description

Informed, written consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Age < 18 years or Age > 75 years
Description

Age < 18 years or Age > 75 years

Data type

boolean

Alias
UMLS CUI-1
C0001779
Active bleeding
Description

Active bleeding

Data type

boolean

Alias
UMLS CUI-1
C0019080
bleeding diathesis
Description

bleeding diathesis

Data type

boolean

Alias
UMLS CUI-1
C3251812
coagulopathy
Description

coagulopathy

Data type

boolean

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

Increased risk of bradycardiac events

Data type

boolean

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

History of gastrointestinal bleeding <2 months

Data type

boolean

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

History of genitourinary bleeding <2 months

Data type

boolean

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

Major surgery in the last 6 weeks

Data type

boolean

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

History of intracranial bleeding or structural abnormalities

Data type

boolean

Alias
UMLS CUI-1
C0151699
Suspected aortic dissection
Description

Suspected aortic dissection

Data type

boolean

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

Administration in the week before the index event of clopidogrel

Data type

boolean

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

Administration in the week before the index event of ticlopidine

Data type

boolean

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

Administration in the week before the index event of prasugrel

Data type

boolean

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

Administration in the week before the index event of ticagrelor

Data type

boolean

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

Administration in the week before the index event of thrombolytics

Data type

boolean

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

Administration in the week before the index event of bivalirudin

Data type

boolean

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

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

Data type

boolean

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

Administration in the week before the index event of fondaparinux

Data type

boolean

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

Concomitant oral or IV therapy with strong CYP3A inhibitors

Data type

boolean

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

Concomitant oral or IV therapy with strong CYP3A inducers

Data type

boolean

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

Known relevant hematological deviations: Hb <10 g/dl

Data type

boolean

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

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

Data type

boolean

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

Use of coumadin derivatives within the last 7 days

Data type

boolean

Alias
UMLS CUI-1
C0043031
Known severe liver disease
Description

Known severe liver disease

Data type

boolean

Alias
UMLS CUI-1
C0085605
severe renal failure
Description

severe renal failure

Data type

boolean

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

Known allergy to the study medications

Data type

boolean

Alias
UMLS CUI-1
C0013182
Pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI-1
C0549206
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
C0021430 (UMLS CUI [1])
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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