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

Primary Purpose

Acute Coronary Syndrome, Adverse Reaction to Antiplatelet Agent

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ticagrelor mashed pills
Ticagrelor integral pills
Sponsored by
David Antoniucci
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Ticagrelor, antiplatelet, Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients presenting within 12 hours from the onset of symptoms with STEMI
  • Informed, written consent

Exclusion Criteria:

  • Age < 18 years or Age > 75 years
  • Active bleeding; bleeding diathesis; coagulopathy
  • Increased risk of bradycardiac events
  • History of gastrointestinal or genitourinary bleeding <2 months
  • Major surgery in the last 6 weeks
  • History of intracranial bleeding or structural abnormalities
  • Suspected aortic dissection
  • Any other condition that may put the patient at risk or influence study results or investigator's opinion (severe hemodynamic instability, known malignancies or other comorbid conditions with life expectancy <1 year)
  • Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux .
  • Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic windows
  • Known relevant hematological deviations: Hb <10 g/dl, Thrombi. <100x10^9/l
  • Use of coumadin derivatives within the last 7 days
  • Chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine
  • Known severe liver disease, severe renal failure
  • Known allergy to the study medications
  • Pregnancy

Sites / Locations

  • Department of Cardiology, Patras University Hospital
  • Careggi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor mashed pills

Ticagrelor integral pills

Arm Description

Ticagrelor loading dose (LD) 180 mg as mashed pills

Ticagrelor loading dose (LD) 180 mg as integral pills

Outcomes

Primary Outcome Measures

Residual Platelet Reactivity
residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD.

Secondary Outcome Measures

High Residual Platelet Reactivity
The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour after ticagrelor LD.
Bleeding Events
Percentage of participants with Major, minor, minimal bleeding (TIMI criteria) events
Dyspnoea and/or Symptomatic Bradycardia
Percentage of participants with Occurrence of dyspnoea and/or symptomatic bradycardia

Full Information

First Posted
November 19, 2013
Last Updated
March 4, 2015
Sponsor
David Antoniucci
Collaborators
AstraZeneca, A.R. CARD Onlus Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01992523
Brief Title
Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? )
Official Title
Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? )
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Antoniucci
Collaborators
AstraZeneca, A.R. CARD Onlus Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Adverse Reaction to Antiplatelet Agent
Keywords
Ticagrelor, antiplatelet, Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor mashed pills
Arm Type
Experimental
Arm Description
Ticagrelor loading dose (LD) 180 mg as mashed pills
Arm Title
Ticagrelor integral pills
Arm Type
Active Comparator
Arm Description
Ticagrelor loading dose (LD) 180 mg as integral pills
Intervention Type
Drug
Intervention Name(s)
Ticagrelor mashed pills
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ticagrelor integral pills
Intervention Description
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).
Primary Outcome Measure Information:
Title
Residual Platelet Reactivity
Description
residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
High Residual Platelet Reactivity
Description
The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour after ticagrelor LD.
Time Frame
1 hour
Title
Bleeding Events
Description
Percentage of participants with Major, minor, minimal bleeding (TIMI criteria) events
Time Frame
48 hours
Title
Dyspnoea and/or Symptomatic Bradycardia
Description
Percentage of participants with Occurrence of dyspnoea and/or symptomatic bradycardia
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients presenting within 12 hours from the onset of symptoms with STEMI Informed, written consent Exclusion Criteria: Age < 18 years or Age > 75 years Active bleeding; bleeding diathesis; coagulopathy Increased risk of bradycardiac events History of gastrointestinal or genitourinary bleeding <2 months Major surgery in the last 6 weeks History of intracranial bleeding or structural abnormalities Suspected aortic dissection Any other condition that may put the patient at risk or influence study results or investigator's opinion (severe hemodynamic instability, known malignancies or other comorbid conditions with life expectancy <1 year) Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux . Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic windows Known relevant hematological deviations: Hb <10 g/dl, Thrombi. <100x10^9/l Use of coumadin derivatives within the last 7 days Chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine Known severe liver disease, severe renal failure Known allergy to the study medications Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Parodi, MD
Organizational Affiliation
Careggi Hospital, Division of Invasive Cardiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Antoniucci, MD
Organizational Affiliation
Careggi Hospital, Division of Invasive Cardiology
Official's Role
Study Director
Facility Information:
Facility Name
Department of Cardiology, Patras University Hospital
City
Patras
Country
Greece
Facility Name
Careggi Hospital
City
Florence
Country
Italy

12. IPD Sharing Statement

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

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