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

David Antoniucci

Status and phase: Completed; Phase 3

Conditions: Acute Coronary Syndrome; Adverse Reaction to Antiplatelet Agent

Treatments: Drug: Ticagrelor mashed pills; Drug: Ticagrelor integral pills

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01992523

MOJITO Study

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Ticagrelor mashed pills

Experimental group

Description:

Ticagrelor loading dose (LD) 180 mg as mashed pills

Treatment:

Drug: Ticagrelor mashed pills

Ticagrelor integral pills

Active Comparator group

Description:

Ticagrelor loading dose (LD) 180 mg as integral pills

Treatment:

Drug: Ticagrelor integral pills