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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| A.R. CARD Onlus Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor mashed pills | Experimental | Ticagrelor loading dose (LD) 180 mg as mashed pills |
|
| Ticagrelor integral pills | Active Comparator | Ticagrelor loading dose (LD) 180 mg as integral pills |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor mashed pills | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Platelet Reactivity | residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD. | 1 hour |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guido Parodi, MD | Careggi Hospital, Division of Invasive Cardiology | Principal Investigator |
| David Antoniucci, MD | Careggi Hospital, Division of Invasive Cardiology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Patras University Hospital | Pátrai | Greece | ||||
| Careggi Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Residual Platelet Reactivity | residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD. | 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. | Posted | Median | Inter-Quartile Range | PRU (P2Y12 reaction units) | 1 hour |
|
Intra-hospital events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ticagrelor Mashed Group | patients taking orally 180 mg ticagrelor mashed tablets |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Cardiac disorders | Systematic Assessment | Cardiovascular and non cardiovascular death |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| TIMI minor bleeding (TIMI criteria) | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guido Parodi | Careggi Hospital | 00390557947732 | parodiguido@gmail.com |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| Ticagrelor integral pills | Drug | 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). |
|
| 48 hours |
| Dyspnoea and/or Symptomatic Bradycardia | Percentage of participants with Occurrence of dyspnoea and/or symptomatic bradycardia | 6 months |
| Florence |
| Italy |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | High Residual Platelet Reactivity | The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour after ticagrelor LD. | Categorical data were expressed as proportions (%) | Posted | Number | percentage of partecipants | 1 hour |
|
|
|
| Secondary | Bleeding Events | Percentage of participants with Major, minor, minimal bleeding (TIMI criteria) events | Posted | Number | percentage of partecipants | 48 hours |
|
|
|
| Secondary | Dyspnoea and/or Symptomatic Bradycardia | Percentage of participants with Occurrence of dyspnoea and/or symptomatic bradycardia | Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%) | Posted | Number | percentage of partecipants | 6 months |
|
|
|
| 2 |
| 41 |
| 9 |
| 41 |
| EG001 | Ticagrelor Integral Group | patients taking orally 180 mg ticagrelor integral tablets | 2 | 41 | 8 | 41 |
|
| Re-infarction | Cardiac disorders | Systematic Assessment |
|
| stroke | Vascular disorders | Systematic Assessment |
|
| Major bleeding (TIMI criteria) | Vascular disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ventricular pauses >= 3 sec | Cardiac disorders | Systematic Assessment |
|
| Serum creatinine increase | Renal and urinary disorders | Systematic Assessment |
|
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