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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Careggi Hospital
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: February 13, 2014
Last verified: February 2014

November 19, 2013
February 13, 2014
November 2013
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01992523 on ClinicalTrials.gov Archive Site
  • 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
  • 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 > 240) 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
Not Provided
Not Provided
 
Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? )
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 with bivalirudin monotherapy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Coronary Syndrome
  • Adverse Reaction to Antiplatelet Agent
  • 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.
  • 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).
  • Experimental: Ticagrelor mashed pills
    Ticagrelor loading dose (LD) 180 mg as mashed pills
    Intervention: Drug: Ticagrelor mashed pills
  • Active Comparator: Ticagrelor integral pills
    Ticagrelor loading dose (LD) 180 mg as integral pills
    Intervention: Drug: Ticagrelor integral pills
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
April 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Guido Parodi, MD +390557947732 parodiguido@gmail.com
Greece,   Italy
 
NCT01992523
MOJITO Study
Yes
David Antoniucci, Careggi Hospital
David Antoniucci
  • AstraZeneca
  • A.R. CARD Onlus Foundation
Principal Investigator: Guido Parodi, MD Careggi Hospital, Division of Invasive Cardiology
Study Director: David Antoniucci, MD Careggi Hospital, Division of Invasive Cardiology
Careggi Hospital
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP