Phase 3
Completed N=82
Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? )
Coronary Artery Disease · Adverse Reaction to Antiplatelet Agent
Source: ClinicalTrials.gov NCT01992523 ↗
Enrolled (actual)
82
Serious AEs
4.9%
Results posted
Mar 2015
Primary outcomePrimary: Residual Platelet Reactivity — 168; 252 PRU (P2Y12 reaction units) — p=0.006
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual Platelet Reactivity |
168; 252 | 0.006 sig |
| SECONDARY High Residual Platelet Reactivity |
35; 63 | — |
| SECONDARY Bleeding Events |
2.4; 7 | — |
| SECONDARY Dyspnoea and/or Symptomatic Bradycardia |
12; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Patients presenting within 12 hours from the onset of symptoms with STEMI
- Informed, written consent
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01992523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.