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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Coronary Syndrome, Adverse Reaction to Antiplatelet Agent

Intervention / Treatment
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* Drug: Ticagrelor mashed pills
* Drug: Ticagrelor integral pills


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor mashed pills<br>Ticagrelor loading dose (LD) 180 mg as mashed pills | Drug: Ticagrelor mashed pills<br>* 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.<br>|
| Active Comparator: Ticagrelor integral pills<br>Ticagrelor loading dose (LD) 180 mg as integral pills | Drug: Ticagrelor integral pills<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual Platelet Reactivity | residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Residual Platelet Reactivity | The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour after ticagrelor LD. | 1 hour | 
| Bleeding Events | Percentage of participants with Major, minor, minimal bleeding (TIMI criteria) events | 48 hours | 
| Dyspnoea and/or Symptomatic Bradycardia | Percentage of participants with Occurrence of dyspnoea and/or symptomatic bradycardia | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ticagrelor, antiplatelet, Acute Coronary Syndrome