Trial Outcomes & Findings for Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? ) (NCT NCT01992523)
NCT ID: NCT01992523
Last Updated: 2015-03-17
Results Overview
residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
82 participants
Primary outcome timeframe
1 hour
Results posted on
2015-03-17
Participant Flow
Participant milestones
| Measure |
Ticagrelor Mashed Pills
Ticagrelor loading dose (LD) 180 mg as mashed pills
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
Ticagrelor loading dose (LD) 180 mg as integral pills
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).
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
41
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? )
Baseline characteristics by cohort
| Measure |
Ticagrelor Mashed Pills
n=41 Participants
Ticagrelor loading dose (LD) 180 mg as mashed pills
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
n=41 Participants
Ticagrelor loading dose (LD) 180 mg as integral pills
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).
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 13 • n=99 Participants
|
61 years
STANDARD_DEVIATION 14 • n=107 Participants
|
62 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Region of Enrollment
Greece
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
26 participants
n=99 Participants
|
26 participants
n=107 Participants
|
52 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 hourPopulation: 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.
residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD.
Outcome measures
| Measure |
Ticagrelor Mashed Pills
n=41 Participants
|
Ticagrelor Integral Pills
n=41 Participants
|
|---|---|---|
|
Residual Platelet Reactivity
|
168 PRU (P2Y12 reaction units)
Interval 61.0 to 251.0
|
252 PRU (P2Y12 reaction units)
Interval 167.0 to 301.0
|
SECONDARY outcome
Timeframe: 1 hourPopulation: Categorical data were expressed as proportions (%)
The percent of patients with a high residual platelet reactivity (PRU \> 208) 1 hour after ticagrelor LD.
Outcome measures
| Measure |
Ticagrelor Mashed Pills
n=41 Participants
|
Ticagrelor Integral Pills
n=41 Participants
|
|---|---|---|
|
High Residual Platelet Reactivity
|
35 percentage of partecipants
|
63 percentage of partecipants
|
SECONDARY outcome
Timeframe: 48 hoursPercentage of participants with Major, minor, minimal bleeding (TIMI criteria) events
Outcome measures
| Measure |
Ticagrelor Mashed Pills
n=41 Participants
|
Ticagrelor Integral Pills
n=41 Participants
|
|---|---|---|
|
Bleeding Events
|
2.4 percentage of partecipants
|
7 percentage of partecipants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%)
Percentage of participants with Occurrence of dyspnoea and/or symptomatic bradycardia
Outcome measures
| Measure |
Ticagrelor Mashed Pills
n=41 Participants
|
Ticagrelor Integral Pills
n=41 Participants
|
|---|---|---|
|
Dyspnoea and/or Symptomatic Bradycardia
|
12 percentage of partecipants
|
12 percentage of partecipants
|
Adverse Events
Ticagrelor Mashed Group
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Ticagrelor Integral Group
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ticagrelor Mashed Group
n=41 participants at risk
patients taking orally 180 mg ticagrelor mashed tablets
|
Ticagrelor Integral Group
n=41 participants at risk
patients taking orally 180 mg ticagrelor integral tablets
|
|---|---|---|
|
Cardiac disorders
death
|
2.4%
1/41 • Number of events 1 • Intra-hospital events
|
2.4%
1/41 • Number of events 1 • Intra-hospital events
|
|
Cardiac disorders
Re-infarction
|
2.4%
1/41 • Number of events 1 • Intra-hospital events
|
0.00%
0/41 • Intra-hospital events
|
|
Vascular disorders
stroke
|
0.00%
0/41 • Intra-hospital events
|
0.00%
0/41 • Intra-hospital events
|
|
Vascular disorders
Major bleeding (TIMI criteria)
|
0.00%
0/41 • Intra-hospital events
|
2.4%
1/41 • Number of events 1 • Intra-hospital events
|
Other adverse events
| Measure |
Ticagrelor Mashed Group
n=41 participants at risk
patients taking orally 180 mg ticagrelor mashed tablets
|
Ticagrelor Integral Group
n=41 participants at risk
patients taking orally 180 mg ticagrelor integral tablets
|
|---|---|---|
|
Vascular disorders
TIMI minor bleeding (TIMI criteria)
|
2.4%
1/41 • Number of events 1 • Intra-hospital events
|
4.9%
2/41 • Number of events 2 • Intra-hospital events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.2%
5/41 • Number of events 5 • Intra-hospital events
|
9.8%
4/41 • Number of events 4 • Intra-hospital events
|
|
Cardiac disorders
Ventricular pauses >= 3 sec
|
0.00%
0/41 • Intra-hospital events
|
2.4%
1/41 • Number of events 1 • Intra-hospital events
|
|
Renal and urinary disorders
Serum creatinine increase
|
7.3%
3/41 • Number of events 3 • Intra-hospital events
|
2.4%
1/41 • Number of events 1 • Intra-hospital events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place