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

NCT01992523 | Completed Phase 3 Results DMC

• 1 other identifier: MOJITO Study
• Study Type: interventional
• Target: 82
• Locations: 2 countries
• Sites: 2

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.

Conditions

Acute Coronary Syndrome; Adverse Reaction to Antiplatelet Agent

Keywords

Ticagrelor; antiplatelet; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Residual Platelet Reactivity

  residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD.

  1 hour

Secondary Outcomes (3)

• High Residual Platelet Reactivity

  1 hour

• Bleeding Events

  48 hours

• Dyspnoea and/or Symptomatic Bradycardia

  6 months

Study Arms (2)

Ticagrelor mashed pills

EXPERIMENTAL

Ticagrelor loading dose (LD) 180 mg as mashed pills

Drug: Ticagrelor mashed pills

Ticagrelor integral pills

ACTIVE COMPARATOR

Ticagrelor loading dose (LD) 180 mg as integral pills

Drug: Ticagrelor integral pills

Interventions

Ticagrelor mashed pills DRUG

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.

Ticagrelor mashed pills

Ticagrelor integral pills DRUG

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).

Ticagrelor integral pills

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting within 12 hours from the onset of symptoms with STEMI
• Informed, written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• David Antoniucci: lead
• AstraZeneca: collaborator
• A.R. CARD Onlus Foundation: collaborator

Study Sites (2)

Department of Cardiology, Patras University Hospital

Pátrai, Greece

Location

Careggi Hospital

Florence, Italy

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Guido Parodi
• Organization: Careggi Hospital

parodiguido@gmail.com

00390557947732

Study Officials

• Guido Parodi, MD

  Careggi Hospital, Division of Invasive Cardiology

  PRINCIPAL INVESTIGATOR

• David Antoniucci, MD

  Careggi Hospital, Division of Invasive Cardiology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Division of Invasive Cardiology

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 25, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 17, 2015
• Results First Posted: March 17, 2015

Record last verified: 2015-03

Locations

GR (1); IT (1)