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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992523
• Other study ID #: MOJITO Study
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2013
• Last updated: March 4, 2015
• Start date: November 2013
• Est. completion date: April 2014

Study information

• Verified date: March 2015
• Source: Careggi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Adverse Reaction to Antiplatelet Agent

Intervention

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.
• 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).

Locations

Country	Name	City	State
Greece	Department of Cardiology, Patras University Hospital	Patras
Italy	Careggi Hospital	Florence

Sponsors (3)

Lead Sponsor	Collaborator
David Antoniucci	A.R. CARD Onlus Foundation, AstraZeneca

Countries where clinical trial is conducted

Greece,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual Platelet Reactivity	residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD.	1 hour	No
Secondary	High Residual Platelet Reactivity	The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour after ticagrelor LD.	1 hour	No
Secondary	Bleeding Events	Percentage of participants with Major, minor, minimal bleeding (TIMI criteria) events	48 hours	Yes
Secondary	Dyspnoea and/or Symptomatic Bradycardia	Percentage of participants with Occurrence of dyspnoea and/or symptomatic bradycardia	6 months	Yes