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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01992523
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : March 17, 2015
Last Update Posted : March 17, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Adverse Reaction to Antiplatelet Agent Drug: Ticagrelor mashed pills Drug: Ticagrelor integral pills Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? )
Study Start Date : November 2013
Primary Completion Date : March 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ticagrelor mashed pills
Ticagrelor loading dose (LD) 180 mg as mashed pills
Drug: 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.
Active Comparator: Ticagrelor integral pills
Ticagrelor loading dose (LD) 180 mg as integral pills
Drug: 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).


Outcome Measures

Primary Outcome Measures :
  1. Residual Platelet Reactivity [ Time Frame: 1 hour ]
    residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD.


Secondary Outcome Measures :
  1. High Residual Platelet Reactivity [ Time Frame: 1 hour ]
    The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour after ticagrelor LD.

  2. Bleeding Events [ Time Frame: 48 hours ]
    Percentage of participants with Major, minor, minimal bleeding (TIMI criteria) events

  3. Dyspnoea and/or Symptomatic Bradycardia [ Time Frame: 6 months ]
    Percentage of participants with Occurrence of dyspnoea and/or symptomatic bradycardia


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992523


Locations
Greece
Department of Cardiology, Patras University Hospital
Patras, Greece
Italy
Careggi Hospital
Florence, Italy
Sponsors and Collaborators
David Antoniucci
AstraZeneca
A.R. CARD Onlus Foundation
Investigators
Principal Investigator: Guido Parodi, MD Careggi Hospital, Division of Invasive Cardiology
Study Director: David Antoniucci, MD Careggi Hospital, Division of Invasive Cardiology
More Information

Responsible Party: David Antoniucci, Director, Division of Invasive Cardiology, Careggi Hospital
ClinicalTrials.gov Identifier: NCT01992523     History of Changes
Other Study ID Numbers: MOJITO Study
First Posted: November 25, 2013    Key Record Dates
Results First Posted: March 17, 2015
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by David Antoniucci, Careggi Hospital:
Ticagrelor
antiplatelet
Acute Coronary Syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs