Acute Coronary SyndromePhase 3NCT01992523

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

A Phase 3 study testing Ticagrelor mashed pills and Ticagrelor integral pills in people with Acute Coronary Syndrome and Adverse Reaction to Antiplatelet Agent, run by David Antoniucci at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Coronary Syndrome, Adverse Reaction to Antiplatelet Agent
What is being tested?: Ticagrelor mashed pills and Ticagrelor integral pills
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 2 sitesin 2 countries
Study dates: Nov 2013to Apr 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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 locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Greece1 site

Department of Cardiology, Patras University Hospital
Pátrai

Other trials in Greece

Italy1 site

Careggi Hospital
Florence

Other trials in Italy

About this study

Conditions: Acute Coronary Syndrome, Adverse Reaction to Antiplatelet Agent
Being tested: Ticagrelor mashed pills, Ticagrelor integral pills
Keywords: Ticagrelor, antiplatelet, Acute Coronary Syndrome
Medical subject headings: Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ticagrelor mashed pillsDrug
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 pillsDrug
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).

Study groups in NCT01992523
Study group	Role	What they receive
Ticagrelor mashed pills	Experimental	Ticagrelor loading dose (LD) 180 mg as mashed pills Receives: Drug: Ticagrelor mashed pills
Ticagrelor integral pills	Active comparator	Ticagrelor loading dose (LD) 180 mg as integral pills Receives: Drug: Ticagrelor integral pills

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Apr 2014

First posted25 Nov 2013 (estimated)
Study startNov 2013
Primary completionMar 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01992523
Sponsor's protocol ID: MOJITO Study
Status last verified: Mar 2015
First submitted: 19 Nov 2013
Last updated: 17 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Coronary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? )
ClinicalTrials.gov ID: NCT01992523
Acronym / sponsor ID: MOJITO Study
Conditions: Acute Coronary Syndrome, Adverse Reaction to Antiplatelet Agent
Keywords: Ticagrelor, antiplatelet, Acute Coronary Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: David AntoniucciUniversity, hospital or other
Collaborators: AstraZeneca, A.R. CARD Onlus Foundation
Study start: Nov 2013
Primary completion: Mar 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 25 Nov 2013 (estimated)
Results: Posted 17 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ticagrelor mashed pills	Experimental	Drug: Ticagrelor mashed pillsTicagrelor loading dose (LD) 180 mg as mashed pills
Ticagrelor integral pills	Active comparator	Drug: Ticagrelor integral pillsTicagrelor loading dose (LD) 180 mg as integral pills

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ticagrelor mashed pillsThe 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.	Drug	Ticagrelor mashed pills
Ticagrelor integral pillsThe 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).	Drug	Ticagrelor integral pills

Primary outcome

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

3 secondary outcomes

High Residual Platelet Reactivity
Time frame: 1 hour
Bleeding Events
Time frame: 48 hours
Dyspnoea and/or Symptomatic Bradycardia
Time frame: 6 months

Results and safety

Results posted to the registry on 17 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ticagrelor Mashed Pills	41	41
Ticagrelor Integral Pills	41	41

Primary outcome: Residual Platelet Reactivity

Time frame: 1 hour. Median (Inter-Quartile Range). Unit: PRU (P2Y12 reaction units)

Measure	Ticagrelor Mashed Pills n = 41	Ticagrelor Integral Pills n = 41
Value	168 (61 to 251)	252 (167 to 301)

Ticagrelor Mashed Pills vs Ticagrelor Integral Pills: p = 0.006, t-test, 2 sided

Population analysed: Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%). A P value \< .05 was considered statistically significant. All tests were two-sided.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Intra-hospital events. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ticagrelor Mashed Group	2 of 41 (4.9%)	9 of 41 (22%)	Not reported
Ticagrelor Integral Group	2 of 41 (4.9%)	8 of 41 (19.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Guido Parodi, MD principal investigator

Careggi Hospital, Division of Invasive Cardiology

David Antoniucci, MD study director

Careggi Hospital, Division of Invasive Cardiology

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Greece, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Residual Platelet Reactivity (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01992523.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.