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

NCT01992523 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2015-03-17

Study results available
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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.

Conditions

  • Acute Coronary Syndrome
  • Adverse Reaction to Antiplatelet Agent

Interventions

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).

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • A.R. CARD Onlus Foundation

    collaborator OTHER

  • David Antoniucci

    lead OTHER

Principal Investigators

  • Guido Parodi, MD · Careggi Hospital, Division of Invasive Cardiology

  • David Antoniucci, MD · Careggi Hospital, Division of Invasive Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-03-31
Completion
2014-04-30

Countries

  • Greece
  • Italy

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01992523 on ClinicalTrials.gov