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The study is designed to assess safety and effects of vorapaxar, when added to standard of care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study may also provide information about the effect of vorapaxar on preventing heart attack and stroke in this subject population.
The study drug (loading dose) is administered at least 1 hour before catheterization for diagnostic imaging or percutaneous coronary interventions (PCI). The incidence of bleeding is thought to be an important index to assess the safety of this drug, therefore thrombolysis in myocardial infarction (TIMI) is evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vorapaxar 20 mg/1 mg | Experimental | Vorapaxar 20 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine) |
|
| Vorapaxar 20 mg/2.5 mg | Experimental | Vorapaxar 20 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine) |
|
| Vorapaxar 40 mg/1 mg | Experimental | Vorapaxar 40 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine) |
|
| Vorapaxar 40 mg/2.5 mg | Experimental | Vorapaxar 40 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine) |
|
| Placebo | Placebo Comparator | Placebo loading dose + daily placebo maintenance dose + standard of care (Aspirin + Ticlopidine) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vorapaxar | Drug | Oral tablets; single 20-mg or 40-mg loading dose on first day followed by daily 1-mg or 2.5-mg maintenance dose for 59 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI) | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. | Up to Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Non-Major Adverse Cardiac Events (MACE) Who Underwent PCI | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading/maintenance dose group. |
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Inclusion Criteria:
Men and women aged 18 years or more with history of cardiac ischemia related chest discomfort of > 10 minutes duration < 24 hours prior to randomization, and having at least 1 of the following A or B. Participants who are planned to undergo PCI will be the target participants.
Willing to give appropriate informed consent and complete all study-related procedures, and able to adhere to dosing and all visit schedules.
Women of child-bearing potential (all postmenarchal women who are <1 years menopausal or who have not had surgical sterilization or a hysterectomy are considered to be women of child-bearing potential) must agree to use a medically accepted method of contraception while receiving protocol-specified medication, and for 60 days after stopping the medication.
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20124733 | Result | Goto S, Yamaguchi T, Ikeda Y, Kato K, Yamaguchi H, Jensen P. Safety and exploratory efficacy of the novel thrombin receptor (PAR-1) antagonist SCH530348 for non-ST-segment elevation acute coronary syndrome. J Atheroscler Thromb. 2010 Feb 26;17(2):156-64. doi: 10.5551/jat.3038. Epub 2010 Feb 3. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
Of 120 participants enrolled and randomized to treatment, 117 participants were treated with study drug. 92 participants underwent percutaneous coronary intervention (PCI) and 25 did not.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vorapaxar 20 mg (PCI) | Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
| FG001 | Vorapaxar 40 mg (PCI) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Oral tablets; matching placebo for SCH 530348 loading and maintenance doses for 59 days |
|
| Aspirin | Drug | Loading dose of 75-325 mg on Day 1, then 75-100 mg once daily for 60 days. |
|
|
| Clopidogrel | Drug | 100 mg two or three times daily for 60 days. |
|
| Up to Day 121 |
| Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI | Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo magnetic resonance imaging [MRI]), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by maintenance dose group. | Up to Day 60 |
| Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit | Blood samples were collected from participants at Baseline and Days 30, 60, 74, 90, and 121 to determine the extent of inhibition of platelet aggregation induced by thrombin-receptor agonist peptide (TRAP). Analysis of data was by maintenance dose group. | Baseline, Day 30, Day 60, Day 74, Day 90, Day 121 |
| Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit | Participant blood samples were collected at Baseline and on Days 30 and 60 to evaluate the median level of hs-CRP. hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation. Analysis of data was by maintenance dose group. | Baseline, Day 30, Day 60 |
| Mean CD40 Ligand Levels Among Participants Who Underwent PCI | Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of CD40 ligand present. CD40 ligand is a protein primarily found on activated T-cells, with higher levels indicating better immunological health. Analysis of data was by maintenance dose group. | Baseline, Day 30, Day 60 |
| Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI | Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of membrane-bound P-selectin. Membrane-bound P-selectin was measured using flow cytometry and a monoclonal antibody to P-selectin. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels. Analysis of data was by maintenance dose group. | Baseline, Day 30, Day 60 |
| Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge | Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring hospitalization, or TIMI major bleeding. Analysis of data was by loading/maintenance dose group. | Up to Day 121 |
| Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI | Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by loading dose group. | Up to Day 60 |
| Number of Participants Experiencing Non-MACE AEs Among Participants Who Did Not Undergo PCI | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal MI, nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading dose group. | Up to Day 121 |
| Number of Participants Who Did Not Undergo PCI But Had Coronary Artery Bypass Graft (CABG) Who Experienced Bleeding Events | Bleeding events were evaluated up to 10 hours post-CABG among participants who did not undergo PCI. | Up to 10 Hours Post-CABG |
| Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Transfusion | Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants that required blood transfusion. Analysis of data was by loading dose group. | Up to Day 60 |
| Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Subsequent Hospitalization | Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants who required a subsequent hospitalization. Analysis of data was by loading dose group. | Up to Day 30 |
| Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI | Participant blood samples were collected at baseline and at the time of hospital discharge to determine the median serum level of hs-CRP. Analysis of data was by loading dose group. | Baseline Up To Day 60 |
| Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI | Participant blood samples were collected at baseline and at the time of hospital discharge to determine the mean serum level of CD40 ligand. Analysis of data was by loading dose group. | Baseline Up To Day 60 |
| Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events | Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring blood transfusion, bleeding requiring hospitalization, and TIMI major bleeding. Analysis of data was by loading dose group. | Baseline Up To Day 60 |
Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
| FG002 | Placebo/Placebo (PCI) | Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
| FG003 | Vorapaxar 20 mg (Non-PCI) | Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days). |
| FG004 | Vorapaxar 40 mg (Non-PCI) | Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
| FG005 | Placebo/Placebo (Non-PCI) | Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vorapaxar 20 mg (PCI) | Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
| BG001 | Vorapaxar 40 mg (PCI) | Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
| BG002 | Placebo/Placebo (PCI) | Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
| BG003 | Vorapaxar 20 mg (Non-PCI) | Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days). |
| BG004 | Vorapaxar 40 mg (Non-PCI) | Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
| BG005 | Placebo/Placebo (Non-PCI) | Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI) | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. | The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI. | Posted | Number | Participants | Up to Day 60 |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Non-Major Adverse Cardiac Events (MACE) Who Underwent PCI | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading/maintenance dose group. | The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with Non-Major MACE data available. | Posted | Number | Participants | Up to Day 121 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI | Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo magnetic resonance imaging [MRI]), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by maintenance dose group. | The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with TIMI bleeding data available. | Posted | Number | Participants | Up to Day 60 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit | Blood samples were collected from participants at Baseline and Days 30, 60, 74, 90, and 121 to determine the extent of inhibition of platelet aggregation induced by thrombin-receptor agonist peptide (TRAP). Analysis of data was by maintenance dose group. | The population consisted of all enrolled participants who received at least 1 dose of study drug and underwent PCI with inhibition of platelet aggregation data available. | Posted | Number | Participants | Baseline, Day 30, Day 60, Day 74, Day 90, Day 121 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit | Participant blood samples were collected at Baseline and on Days 30 and 60 to evaluate the median level of hs-CRP. hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation. Analysis of data was by maintenance dose group. | The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with hs-CRP data available. | Posted | Median | Inter-Quartile Range | mg/L | Baseline, Day 30, Day 60 |
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| Secondary | Mean CD40 Ligand Levels Among Participants Who Underwent PCI | Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of CD40 ligand present. CD40 ligand is a protein primarily found on activated T-cells, with higher levels indicating better immunological health. Analysis of data was by maintenance dose group. | The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with CD40 ligand data available. | Posted | Mean | Standard Error | ng/mL | Baseline, Day 30, Day 60 |
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| Secondary | Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI | Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of membrane-bound P-selectin. Membrane-bound P-selectin was measured using flow cytometry and a monoclonal antibody to P-selectin. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels. Analysis of data was by maintenance dose group. | The population included all enrolled participants that received at least 1 dose of study drug and underwent PCI with membrane-bound P-selectin data available. | Posted | Mean | Standard Error | Arbitrary Units | Baseline, Day 30, Day 60 |
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| Secondary | Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge | Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring hospitalization, or TIMI major bleeding. Analysis of data was by loading/maintenance dose group. | The population included all participants who received at least 1 dose of study drug, underwent PCI, and had bleeding event data. | Posted | Number | Participants | Up to Day 121 |
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| Secondary | Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI | Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by loading dose group. | The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had TIMI bleeding data available. | Posted | Number | Participants | Up to Day 60 |
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| Secondary | Number of Participants Experiencing Non-MACE AEs Among Participants Who Did Not Undergo PCI | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal MI, nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading dose group. | The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had non-MACE AE data available. | Posted | Number | Participants | Up to Day 121 |
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| Secondary | Number of Participants Who Did Not Undergo PCI But Had Coronary Artery Bypass Graft (CABG) Who Experienced Bleeding Events | Bleeding events were evaluated up to 10 hours post-CABG among participants who did not undergo PCI. | Evaluation of the bleeding events associated with CABG occurring after Vorapaxar treatment was not analyzed since only three participants in the non-PCI cohort underwent CABG in this study. | Posted | Up to 10 Hours Post-CABG |
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| Secondary | Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Transfusion | Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants that required blood transfusion. Analysis of data was by loading dose group. | The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had transfusion data available. | Posted | Number | Participants | Up to Day 60 |
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| Secondary | Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Subsequent Hospitalization | Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants who required a subsequent hospitalization. Analysis of data was by loading dose group. | The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had hospitalization data available. | Posted | Number | Participants | Up to Day 30 |
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| Secondary | Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI | Participant blood samples were collected at baseline and at the time of hospital discharge to determine the median serum level of hs-CRP. Analysis of data was by loading dose group. | The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had hs-CRP data available. | Posted | Median | Standard Deviation | mg/L | Baseline Up To Day 60 |
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| Secondary | Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI | Participant blood samples were collected at baseline and at the time of hospital discharge to determine the mean serum level of CD40 ligand. Analysis of data was by loading dose group. | The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had CD40 ligand data available. | Posted | Mean | Standard Error | ng/mL | Baseline Up To Day 60 |
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| Secondary | Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events | Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring blood transfusion, bleeding requiring hospitalization, and TIMI major bleeding. Analysis of data was by loading dose group. | The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had bleeding event data available. | Posted | Number | Participants | Baseline Up To Day 60 |
|
Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
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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 | Vorapaxar 20 mg/1 mg | Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). | 5 | 25 | 25 | 25 | ||
| EG001 | Vorapaxar 20 mg/2.5 mg | Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). | 4 | 24 | 23 | 24 | ||
| EG002 | Vorapaxar 40 mg/1 mg | Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). | 2 | 22 | 22 | 22 | ||
| EG003 | Vorapaxar 40 mg/2.5 mg | Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). | 2 | 26 | 23 | 26 | ||
| EG004 | Placebo/Placebo | Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days). | 5 | 23 | 22 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cardiac Tamponade | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Supraventricular Extrasystoles | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Ventricle Rupture | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Ventricular Extrasystoles | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Sudden Hearing Loss | Ear and labyrinth disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Malaena | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Post Procedural Haematoma | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Colon Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Loss of Consciousness | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Arteriosclerosis Obliterans | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Ventricular Extrasystoles | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Abdominal Distention | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Gingival Bleeding | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Puncture Site Haemorrhage | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Puncture Site Pain | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Venipuncture Site Swelling | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Gingival Abscess | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Post Procedural Haematoma | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Blood Pressure Decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Blood Triglycerides Increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Blood Urine Present | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Occult Blood | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Occult Blood Positive | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Protein Urine Present | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Hyperchlesterolaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cold Sweat | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Drug Eruption | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Haemorrhage Subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Angiopathy | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
Prior approval by the Sponsor is required before the results obtained in the clinical study can be made public by the investigator (sub-investigator) in a publication or at a medical meeting.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D017202 | Myocardial Ischemia |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| C530299 | vorapaxar |
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
| OG003 | Vorapaxar 40 mg/2.5 mg PCI | Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
| OG004 | Placebo/Placebo PCI | Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
|
|
| OG002 | Placebo/Placebo PCI | Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
|
|
|
|
|
|
|
|
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|
| OG003 | Vorapaxar 40 mg/2.5 mg PCI | Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
| OG004 | Placebo/Placebo PCI | Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
|
|
| OG002 |
| Placebo/Placebo Non-PCI |
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
|
|
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days). |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
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|