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

This study is currently recruiting participants.
Verified February 2014 by Careggi Hospital
Sponsor:
Collaborators:
AstraZeneca
ARCARD ONLUS Foundation
Information provided by (Responsible Party):
David Antoniucci, Careggi Hospital
ClinicalTrials.gov Identifier:
NCT01992523
First received: November 19, 2013
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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 with bivalirudin monotherapy.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? )

Resource links provided by NLM:


Further study details as provided by Careggi Hospital:

Primary Outcome Measures:
  • residual platelet reactivity [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD.


Secondary Outcome Measures:
  • high residual platelet reactivity [ Time Frame: 1, 2 hours ] [ Designated as safety issue: No ]
    The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour and 2 hours after ticagrelor LD.

  • Bleeding events [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    Major, minor, minimal bleeding (TIMI criteria) events

  • Dyspnoea and/or symptomatic bradycardia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Occurrence of dyspnoea and/or symptomatic bradycardia


Estimated Enrollment: 80
Study Start Date: November 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01992523

Contacts
Contact: Guido Parodi, MD +390557947732 parodiguido@gmail.com

Locations
Greece
Department of Cardiology, Patras University Hospital Recruiting
Patras, Greece
Contact: Dimitrios Alexopoulos, MD       dalex@med.upatras.gr   
Principal Investigator: Dimitrios Alexopoulos, MD         
Italy
Careggi Hospital Recruiting
Florence, Italy
Contact: Guido Parodi, MD    +390557947732    parodiguido@gmail.com   
Principal Investigator: Guido Parodi, MD         
Sponsors and Collaborators
David Antoniucci
AstraZeneca
ARCARD 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

No publications provided

Responsible Party: David Antoniucci, Director, Division of Invasive Cardiology, Careggi Hospital
ClinicalTrials.gov Identifier: NCT01992523     History of Changes
Other Study ID Numbers: MOJITO Study
Study First Received: November 19, 2013
Last Updated: February 13, 2014
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Careggi Hospital:
Ticagrelor
antiplatelet
Acute Coronary Syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Contraceptives, Oral
Ticagrelor
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 14, 2014