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The study is designed to assess safety of Vorapaxar when added to standard of care (aspirin) in Japanese subjects with cerebral infarction. The study will assess incidence and tolerability of bleeding, major adverse cardiac events, all adverse events, and effect on expression of markers of inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vorapaxar 2.5 mg + Aspirin | Experimental | Vorapaxar oral tablets; once daily for 60 days + Aspirin. |
|
| Vorapaxar 1 mg + Aspirin | Experimental | Vorapaxar oral tablets; once daily for 60 days + Aspirin. |
|
| Placebo + Aspirin | Placebo Comparator | Placebo oral tablets; once daily for 60 days + Aspirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vorapaxar 2.5 mg | Drug | Oral tablets; once daily for 60 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Non-Major Adverse Cardiac Events (Non-MACE) | An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporarily associated with study drug administration, whether or not considered related to study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization. All MACE events were excluded from this analysis. | Up to Day 121 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Paticipants Experiencing Thrombolysis in Myocardial Infarction (TIMI) Major, Minor, and Non-TIMI Bleeding Events | Major TIMI bleeding was defined as any intracranial bleeding (excluding micohemorrhages <10 mm evident on magnetic resonance imaging [MRI]), clinical over signs of hemorrhge associated with a drop in hemoglobin >=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 a hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI or Minor TIMI bleeding. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20947374 | Result | Shinohara Y, Goto S, Doi M, Jensen P. Safety of the novel protease-activated receptor-1 antagonist vorapaxar in Japanese patients with a history of ischemic stroke. J Stroke Cerebrovasc Dis. 2012 May;21(4):318-24. doi: 10.1016/j.jstrokecerebrovasdis.2010.09.005. Epub 2010 Oct 14. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vorapaxar 1 mg | Vorapaxar 1 mg tablets administered orally once daily for 60 days. |
| FG001 | Vorapaxar 2.5 mg | Vorapaxar 2.5 mg tablets administered orally once daily for 60 days. |
| FG002 | Placebo | Matching placbo tablets to Vorapaxar administered orally once daily for 60 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vorapaxar 1 mg | Vorapaxar 1 mg tablets administered orally once daily for 60 days. |
| BG001 | Vorapaxar 2.5 mg | Vorapaxar 2.5 mg tablets administered orally once daily for 60 days. |
| 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 Experiencing Non-Major Adverse Cardiac Events (Non-MACE) | An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporarily associated with study drug administration, whether or not considered related to study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization. All MACE events were excluded from this analysis. | The population consisted of all enrolled participants that received at least one dose of study drug. | Posted | Number | Participants | Up to Day 121 |
|
Up to Day 121
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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 1 mg | Vorapaxar 1 mg tablets administered orally once daily for 60 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial Fibrillation | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic Diathesis | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| C530299 | vorapaxar |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Vorapaxar 1 mg |
| Drug |
Oral tablets; once daily for 60 days |
|
| Placebo | Drug | oral tablets; once daily for 60 days |
|
| Aspirin 75-150 mg | Drug | oral tablets; once daily for 60 days |
|
| Up to Day 60 |
| Number of Participants With MACE or Death | The number of participants experiencing major cardiac events or death was evaluated up to Day 121. Major cardiac events were defined as nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization. | Up to Day 121 |
| Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels By Study Visit | Participant blood samples were collected to determine the median serum level of hs-CRP. hs-cRP levels reflect the underlying level of inflammation. The higher the level, the greater the disease burden. | Up to Day 60 |
| Mean CD40 Ligand Levels By Study Visit | Participant blood samples were collected to determine the mean serum level of CD40 ligand. CD40 ligand values represent the level of disease activation with a higher level of CD40 ligand indicating a greater underlying risk. | Up to Day 60 |
| Mean Membrane-Bound P-Selectin Levels By Study Visit | Participant blood samples were collected at Baseline, Day 30, and Day 60 to determine the mean level of membrane-bound p-selectin in the serum. Membrane-bound P-selectin levels reflect the underlying level of inflammation. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels. | Up to Day 60 |
| BG002 | Placebo | Matching placbo tablets to Vorapaxar administered orally once daily for 60 days. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Vorapaxar 2.5 mg |
Vorapaxar 2.5 mg tablets administered orally once daily for 60 days. |
| OG002 | Placebo | Matching placbo tablets to Vorapaxar administered orally once daily for 60 days. |
|
|
| Secondary | Number of Paticipants Experiencing Thrombolysis in Myocardial Infarction (TIMI) Major, Minor, and Non-TIMI Bleeding Events | Major TIMI bleeding was defined as any intracranial bleeding (excluding micohemorrhages <10 mm evident on magnetic resonance imaging [MRI]), clinical over signs of hemorrhge associated with a drop in hemoglobin >=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 a hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI or Minor TIMI bleeding. | The population consisted of all enrolled participants that received at least one dose of study drug and had TIMI bleeding data available. | Posted | Number | Participants | Up to Day 60 |
|
|
|
| Secondary | Number of Participants With MACE or Death | The number of participants experiencing major cardiac events or death was evaluated up to Day 121. Major cardiac events were defined as nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization. | The population consisted of all enrolled participants that received at least one dose of study drug. | Posted | Number | Participants | Up to Day 121 |
|
|
|
| Secondary | Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels By Study Visit | Participant blood samples were collected to determine the median serum level of hs-CRP. hs-cRP levels reflect the underlying level of inflammation. The higher the level, the greater the disease burden. | The population consisted of all enrolled participants who received at least one dose of study drug and had hs-CRP data available. | Posted | Median | Standard Deviation | mg/L | Up to Day 60 |
|
|
|
| Secondary | Mean CD40 Ligand Levels By Study Visit | Participant blood samples were collected to determine the mean serum level of CD40 ligand. CD40 ligand values represent the level of disease activation with a higher level of CD40 ligand indicating a greater underlying risk. | The population consisted of all enrolled participants that received at least one dose of study drug and had CD40 ligand data available. | Posted | Mean | Standard Error | mg/L | Up to Day 60 |
|
|
|
| Secondary | Mean Membrane-Bound P-Selectin Levels By Study Visit | Participant blood samples were collected at Baseline, Day 30, and Day 60 to determine the mean level of membrane-bound p-selectin in the serum. Membrane-bound P-selectin levels reflect the underlying level of inflammation. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels. | The population consisted of all enrolled participants that received at least one dose of study drug and had membrane-bound p-selectin data available. | Posted | Mean | Standard Error | Arbitrary Units | Up to Day 60 |
|
|
|
| 1 |
| 33 |
| 26 |
| 33 |
| EG001 | Vorapaxar 2.5 mg | Vorapaxar 2.5 mg tablets administered orally once daily for 60 days. | 2 | 29 | 24 | 29 |
| EG002 | Placebo | Matching placbo tablets to Vorapaxar administered orally once daily for 60 days. | 3 | 28 | 20 | 28 |
| Vertigo | Ear and labyrinth disorders | MedDRA 10.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Oesophageal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Cerebellar Infarction | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Supraventricular Extrasystoles | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Facial Pain | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Feeling Abnormal | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Subcutaneous Haematoma | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood Glucose Increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood Potassium 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 |
|
| Electrocardiogram QT Prolonged | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Occult Blood Positive | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cerebral Infarction | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cervicobrachial Syndrome | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dizziness | 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 |
|
| Eczema | 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 |
|
| 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.
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| Title | Measurements |
|---|---|
|
| Non-TIMI Bleeding |
|
| Title | Measurements |
|---|---|
|
|
| Day 14 (32, 29, 28) |
|
| Day 30 (n=31, 28, 28) |
|
| Day 45 (n=29, 27, 28) |
|
| Day 60 (n=29, 26, 27) |
|
|
| Day 14 (n=32, 29, 28) |
|
| Day 30 (n=31, 28, 28) |
|
| Day 45 (n=29, 27, 28) |
|
| Day 60 (n=29, 26, 27) |
|
| Day 30 (n=2, 1, 3) |
|
| Day 60 (n=2, 1, 3) |
|