NCT00684515已完成2 期
Phase II Study of SCH 530348 in Subjects With Cerebral Infarction
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Number of Participants Experiencing Non-Major Adverse Cardiac Events (Non-MACE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women at least 18 years old with last cerebral infarction (excluding cardiogenic cerebral embolism) having occurred from 14 days to less than 1 year after onset (at the time of obtaining consent), with stable nervous system for more than 24 hours and known course of disease.
- •Participants confirmed to have cerebral infarction lesion by brain computerized tomography (CT) or magnetic resonance imaging (MRI).
- •Both of in-participant and out-participant
- •Willing to give appropriate informed consent and complete all study-related procedures and able to adhere to dosing and visit schedules.
- •Women of child-bearing potential (all postmenopausal women who are <1 year 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 study drug, and for 60 days after completion or discontinuation of the medication.
排除标准
- •Pregnancy and nursing patients (premenopausal women should have a negative pregnancy test result confirmed before enrollment)
- •Participant with any serious complication or any condition that the investigator feels that would cause a significant hazard to the participant if the study drug is administered.
- •Known hypersensitivity to any component of the study drug.
- •Participation in a study or use of an investigational study drug within 30 days before obtaining consent.
- •Member of the staff personnel directly involved with this study
- •Family member of the study staff.
- •History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days before obtaining consent.
- •History of cerebral hemorrhage.
- •Severe hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg).
- •Major surgery within 2 weeks before obtaining consent.
- •Known platelet count <100,000/mm^3
- •Participants confirmed to have cerebral bleeding or any causes of cerebral bleeding by brain CT or MRI.
- •Participants with transient ischemic attack (TIA), progressive stroke or cardiogenic cerebral embolism.
- •Known impairment of renal function (serum creatinine >2.0 mg/dL [>176.8 (umol/L]), dysproteinemia, nephrotic syndrome, or other renal disease
- •Active or chronic hepatobiliary system or hepatic disease, or aspartate aminotransferase (GOT) or alanine aminotransferate (GPT) activity more than two times greater than the upper limit of the laboratory normal range.
- •Participants with contraindictation to aspirin.
- •Scheduled to have PCI (peripheral coronary intervention), peripheral interventional event, carotid endarterectomy, intra- and extra- cranial bypass surgery and intravascular surgery (angioplasty) during the study period.
- •Combination therapy with unfractionated heparin, tissue plasminogen activator, urokinase, warfarin, factor Xa inhibitor, direct thrombin inhibitor or antiplatelet agents other than aspirin after obtaining consent, or scheduled to have the above combination therapy.
- •Any serious impairment which would make detection of new ischemic events difficult (eg, bedridden participants, participants with total nursing care, dementia participants, etc.) or consciousness disturbance which may cause aspiration of the study drug.
研究组 & 干预措施
Vorapaxar 2.5 mg + Aspirin
Experimental
Vorapaxar oral tablets; once daily for 60 days + Aspirin.
干预措施: Vorapaxar 2.5 mg (Drug)
Vorapaxar 2.5 mg + Aspirin
Experimental
Vorapaxar oral tablets; once daily for 60 days + Aspirin.
干预措施: Aspirin 75-150 mg (Drug)
Vorapaxar 1 mg + Aspirin
Experimental
Vorapaxar oral tablets; once daily for 60 days + Aspirin.
干预措施: Vorapaxar 1 mg (Drug)
Vorapaxar 1 mg + Aspirin
Experimental
Vorapaxar oral tablets; once daily for 60 days + Aspirin.
干预措施: Aspirin 75-150 mg (Drug)
Placebo + Aspirin
Placebo Comparator
Placebo oral tablets; once daily for 60 days + Aspirin
干预措施: Placebo (Drug)
Placebo + Aspirin
Placebo Comparator
Placebo oral tablets; once daily for 60 days + Aspirin
干预措施: Aspirin 75-150 mg (Drug)
结局指标
主要结局
Number of Participants Experiencing Non-Major Adverse Cardiac Events (Non-MACE)
时间窗: Up to Day 121
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.
次要结局
- Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels By Study Visit(Up to Day 60)
- Mean CD40 Ligand Levels By Study Visit(Up to Day 60)
- Number of Participants With MACE or Death(Up to Day 121)
- Mean Membrane-Bound P-Selectin Levels By Study Visit(Up to Day 60)
- Number of Paticipants Experiencing Thrombolysis in Myocardial Infarction (TIMI) Major, Minor, and Non-TIMI Bleeding Events(Up to Day 60)
研究者
相似试验
已完成
2 期
Trial to Assess the Safety and Effects of Vorapaxar in Japanese Subjects With Acute Coronary Syndrome (P04772; MK-5348-016)Myocardial InfarctionAtherosclerosisMyocardial IschemiaNCT00684203Merck Sharp & Dohme LLC120
已完成
3 期
Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (P04737)IschemiaCerebrovascular AccidentMyocardial InfarctionAtherosclerosisPeripheral Arterial DiseaseNCT00526474Merck Sharp & Dohme LLC26,449
终止
3 期
Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Particpants With Acute Coronary Syndrome (TRA•CER) (Study P04736)Myocardial InfarctionAtherosclerosisMyocardial IschemiaNCT00527943Merck Sharp & Dohme LLC12,944
撤回
2 期
Study Evaluating Safety and Tolerability of Vabicaserin in Patients With Sudden Worsening of SchizophreniaSchizophreniaNCT00768612Wyeth is now a wholly owned subsidiary of Pfizer
已完成
3 期
A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical PatientsThromboembolismNCT00451412Novartis3,254