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

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
A.R. CARD Onlus Foundation
Information provided by (Responsible Party):
David Antoniucci, Careggi Hospital
ClinicalTrials.gov Identifier:
NCT01992523
First received: November 19, 2013
Last updated: March 4, 2015
Last verified: March 2015
Results First Received: September 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acute Coronary Syndrome
Adverse Reaction to Antiplatelet Agent
Interventions: Drug: Ticagrelor mashed pills
Drug: Ticagrelor integral pills

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ticagrelor Mashed Pills

Ticagrelor loading dose (LD) 180 mg as mashed pills

Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient.

Ticagrelor Integral Pills

Ticagrelor loading dose (LD) 180 mg as integral pills

Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor).


Participant Flow:   Overall Study
    Ticagrelor Mashed Pills     Ticagrelor Integral Pills  
STARTED     41     41  
COMPLETED     41     41  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Ticagrelor Mashed Pills

Ticagrelor loading dose (LD) 180 mg as mashed pills

Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient.

Ticagrelor Integral Pills

Ticagrelor loading dose (LD) 180 mg as integral pills

Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor).

Total Total of all reporting groups

Baseline Measures
    Ticagrelor Mashed Pills     Ticagrelor Integral Pills     Total  
Number of Participants  
[units: participants]
  41     41     82  
Age  
[units: years]
Mean ± Standard Deviation
  64  ± 13     61  ± 14     62  ± 13  
Gender  
[units: participants]
     
Female     10     8     18  
Male     31     33     64  
Region of Enrollment  
[units: participants]
     
Greece     15     15     30  
Italy     26     26     52  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Residual Platelet Reactivity   [ Time Frame: 1 hour ]

2.  Secondary:   High Residual Platelet Reactivity   [ Time Frame: 1 hour ]

3.  Secondary:   Bleeding Events   [ Time Frame: 48 hours ]

4.  Secondary:   Dyspnoea and/or Symptomatic Bradycardia   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Guido Parodi
Organization: Careggi Hospital
phone: 00390557947732
e-mail: parodiguido@gmail.com


No publications provided


Responsible Party: David Antoniucci, Careggi Hospital
ClinicalTrials.gov Identifier: NCT01992523     History of Changes
Other Study ID Numbers: MOJITO Study
Study First Received: November 19, 2013
Results First Received: September 25, 2014
Last Updated: March 4, 2015
Health Authority: Italy: The Italian Medicines Agency