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Enrolling participants has halted prematurely and will not resume
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To compare efficacy and safety of prasugrel and ticagrelor in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.
Prasugrel and ticagrelor are recommended in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Both prasugrel and ticagrelor show more rapid and potent antiplatelet effect compared with clopidogrel. However, previous report comparing the efficacy and safety of prasugrel and ticagrelor in patients with STEMI of East Asian ethnicity is lacking. Therefore, the aim of this study is to compare the antiplatelet efficacy and safety using laboratory platelet function tests and clinical outcomes in patients with STEMI treated with either prasugrel or ticagrelor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasugrel 60 mg | Experimental | Prasugrel 60 mg as loading dose and followed by 10 mg/day as maintenance dose |
|
| Ticagrelor 180 mg | Experimental | Ticagrelor 180 mg as loading dose and followed by 90 mg twice a day as maintenance dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel 60 mg | Drug | Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With High Platelet Reactivity | Platelet reactivity were measured by VerifyNow (volumetrics accuretic，San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. High platelet reactivity (HPR) is defined as the result of P2Y12 reaction units (PRU) >235 and platelet reactivity index (PRI) >50%. | 48 hours after loading dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac and Cerebrovascular Events | Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30. | 30 days |
| Bleeding Event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moo Hyun Kim, M.D. | Dong-A University Hospital, Busan, Republic of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DongA University Hospital | Busan | 602-715 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23500251 | Background | Parodi G, Valenti R, Bellandi B, Migliorini A, Marcucci R, Comito V, Carrabba N, Santini A, Gensini GF, Abbate R, Antoniucci D. Comparison of prasugrel and ticagrelor loading doses in ST-segment elevation myocardial infarction patients: RAPID (Rapid Activity of Platelet Inhibitor Drugs) primary PCI study. J Am Coll Cardiol. 2013 Apr 16;61(15):1601-6. doi: 10.1016/j.jacc.2013.01.024. Epub 2013 Mar 22. | |
| 23169985 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prasugrel | Patient administer Prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose. |
| FG001 | Ticagrelor | Patient administer Ticagrelor 180 mg as loading dose followed by 90 mg twice a day as maintenance dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prasugrel | Patient administer Prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose. |
| BG001 | Ticagrelor | Patients administer Ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose. |
| 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 | Number of Participants With High Platelet Reactivity | Platelet reactivity were measured by VerifyNow (volumetrics accuretic，San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. High platelet reactivity (HPR) is defined as the result of P2Y12 reaction units (PRU) >235 and platelet reactivity index (PRI) >50%. | Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher's exact test, as appropriate. | Posted | Number | participants | 48 hours after loading dose of study drug |
|
1 month
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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 | Prasugrel | Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose. |
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For the present single-center pilot study, the small sample size was a major limitation, and as such was insufficiently powered to assess safety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Moo Hyun Kim; Director of Global Clinical Trial Center Dong-A University Hospital. | Department of Cardiology, College of Medicine, Dong-A University. | +82 (51) 240-2976 | kimmh@dau.ac.kr |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
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| Ticagrelor 180 mg | Drug | Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose. |
|
|
Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria.
| 30 days |
| Adverse Drug Reaction | Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention. | 30 days |
| Pre-procedure P2Y12 Reaction Units (PRU) | Platelet reactivity was measured using VerifyNow (volumetrics accuretic, San Diego, California, USA). Platelet reactivity values were presented as P2Y12 reaction units (PRU). | Baseline |
| Number of Participants With Low Platelet Reactivity | Platelet reactivity were measured using VerifyNow (volumetrics accuretic, San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. Low platelet reactivity (LPR) is defined as the result of P2Y12 reaction units (PRU) <85 and platelet reactivity index (PRI)<16%. The PRU value for LPR, 18 patients were in prasugrel groups and 19 patients in ticagrelor groups, regarding the PRI value for LPR, 16 patients were in each groups. | 48 hours after loading dose of study drug |
| Pre-procedure Platelet Reactivity Index (PRI) | Platelet reactivity was measured using vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay. Platelet reactivity values were presented as platelet reactivity index (PRI). | Baseline |
| Background |
| Alexopoulos D, Xanthopoulou I, Gkizas V, Kassimis G, Theodoropoulos KC, Makris G, Koutsogiannis N, Damelou A, Tsigkas G, Davlouros P, Hahalis G. Randomized assessment of ticagrelor versus prasugrel antiplatelet effects in patients with ST-segment-elevation myocardial infarction. Circ Cardiovasc Interv. 2012 Dec;5(6):797-804. doi: 10.1161/CIRCINTERVENTIONS.112.972323. Epub 2012 Nov 20. |
| 25959558 | Derived | Lee YS, Jin CD, Kim MH, Guo LZ, Cho YR, Park K, Park JS, Park TH, Kim YD. Comparison of Prasugrel and Ticagrelor Antiplatelet Effects in Korean Patients Presenting With ST-Segment Elevation Myocardial Infarction. Circ J. 2015;79(6):1248-54. doi: 10.1253/circj.CJ-15-0270. Epub 2015 May 11. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Ticagrelor | Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose. |
|
|
| Secondary | Major Adverse Cardiac and Cerebrovascular Events | Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30. | Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher's exact test, as appropriate. | Posted | Number | participants | 30 days |
|
|
|
| Secondary | Bleeding Event | Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria. | Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher's exact test, as appropriate. | Posted | Number | participants | 30 days |
|
|
|
| Secondary | Adverse Drug Reaction | Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention. | Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number, compared with chi-square statistics or Fisher's exact test, as appropriate. | Posted | Number | participants | 30 days |
|
|
|
| Secondary | Pre-procedure P2Y12 Reaction Units (PRU) | Platelet reactivity was measured using VerifyNow (volumetrics accuretic, San Diego, California, USA). Platelet reactivity values were presented as P2Y12 reaction units (PRU). | Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as median (Inter-Quartile Range). | Posted | Median | Inter-Quartile Range | PRU units | Baseline |
|
|
|
| Secondary | Number of Participants With Low Platelet Reactivity | Platelet reactivity were measured using VerifyNow (volumetrics accuretic, San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. Low platelet reactivity (LPR) is defined as the result of P2Y12 reaction units (PRU) <85 and platelet reactivity index (PRI)<16%. The PRU value for LPR, 18 patients were in prasugrel groups and 19 patients in ticagrelor groups, regarding the PRI value for LPR, 16 patients were in each groups. | Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher's exact test, as appropriate. | Posted | Number | participants | 48 hours after loading dose of study drug |
|
|
|
| Secondary | Pre-procedure Platelet Reactivity Index (PRI) | Platelet reactivity was measured using vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay. Platelet reactivity values were presented as platelet reactivity index (PRI). | Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as median (Inter-Quartile Range). | Posted | Median | Inter-Quartile Range | percentage | Baseline |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Ticagrelor | Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose. | 0 | 20 | 0 | 20 |
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| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |