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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome; Adverse Reaction to Antiplatelet Agent
• Intervention / Treatment: Drug: Ticagrelor mashed pills; Drug: Ticagrelor integral pills

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 3

Contacts and Locations

Study Locations

• Greece
  • Patras, Greece
    • Department of Cardiology, Patras University Hospital
• Italy
  • Florence, Italy
    • Careggi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual Platelet Reactivity	residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High Residual Platelet Reactivity	The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour after ticagrelor LD.	1 hour
Bleeding Events	Percentage of participants with Major, minor, minimal bleeding (TIMI criteria) events	48 hours
Dyspnoea and/or Symptomatic Bradycardia	Percentage of participants with Occurrence of dyspnoea and/or symptomatic bradycardia	6 months

Collaborators and Investigators

• Sponsor: David Antoniucci
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: November 19, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Ticagrelor; Acute Coronary Syndrome; antiplatelet
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor
• Other Study ID Numbers: MOJITO Study