NCT06710262已完成不适用
T-TAS® wS Method Comparison
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Method agreement
研究概览
简要总结
This study involves the collection of blood samples and measurement with the T-TAS PL assay to compare the performance of the T-TAS wS instrument to the T-TAS 01 instrument
详细描述
This study will compare PL assay measurements obtained with the T-TAS wS instrument (subject device) with PL assay measurements obtained with the T-TAS 01 instrument (predicate method). The T-TAS PL assay will be used to facilitate the comparison between instruments using intended use blood samples from the intended use population. The study will be conducted at a minimum of 3 locations in the United States and will enroll up to 120 subjects. The following subject populations will be enrolled into the study (minimum enrollment numbers indicated in parentheses):
- Ostensibly healthy subjects
- Subjects taking 81 mg or higher daily aspirin monotherapy (ASA)
- Subjects taking dual antiplatelet therapy (DAPT)
- Subjects with von Willebrand disease (VWD)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females age 21 years or older.
- •Able and willing to provide written informed consent.
排除标准
- •Hospitalization or doctor's visits within prior 30 days, except for routine checkup/physical examination.
- •Use of antiplatelet therapy within the past 7 days, e.g. aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol.
- •Use of anticoagulant drugs within the past 7 days, e.g. heparin, bivalirudin, warfarin, rivaroxaban, and apixaban.
- •Use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) that inhibit COX-1 such as naproxen or ibuprofen within the past 3 days, unless confirmed to not inhibit platelet activity (such as celecoxib).
- •History of anemia.
- •Known thrombocytopenia (platelet count < 100,000/μL).
- •Significant renal dysfunction or dialysis.
- •History of platelet disorders e.g. von Willebrand factor deficiency, Glanzmann's thrombasthenia or Bernard-Soulier syndrome.
- •History of hemophilia or bleeding disorders.
- •Known active gastrointestinal disease including peptic ulcers, gastro-esophageal reflux disease (GERD), and hyperacidity.
- •Currently participating in a study involving an investigational drug or compound known to affect coagulation or hemostasis.
- •Subjects with significant past medical history as determined by the Investigator that would pose safety concerns or interfere with the study goals.
- •Antiplatelet Therapy Subjects
- •Inclusion Criteria:
- •Males and females age 21 years or older.
- •One of the following antiplatelet therapy regimens:
- •Aspirin monotherapy:
- •81 mg or higher aspirin daily for 1 or more days
- •Dual antiplatelet therapy:
- •81 mg or higher aspirin plus either 1) ≥300 mg clopidogrel loading dose within the prior 5 days followed by 75 mg daily clopidogrel, or 2) 75 mg daily clopidogrel daily for ≥5 days.
- •81 mg or higher aspirin plus either 1) 60 mg prasugrel loading dose within the prior 5 days followed by either 5 or 10 mg daily prasugrel, or 2) 5 or 10 mg daily prasugrel daily for ≥5 days.
- •81 mg aspirin plus either 1) 180 mg ticagrelor loading dose within the prior 5 days followed by 2x90 mg daily ticagrelor, or 2) 2x90 mg daily ticagrelor daily for ≥5 days.
- •Able and willing to provide written informed consent.
- •Exclusion Criteria:
- •Use of antiplatelet therapy other than aspirin, clopidogrel, prasugrel, or ticagrelor (e.g. cilostazol, abciximab, eptifibatide) within the past 7 days.
- •Use of anticoagulant drugs within the past 7 days, e.g. heparin, bivalirudin, warfarin, rivaroxaban, and apixaban.
- •Significant renal dysfunction or dialysis.
- •Known thrombocytopenia (platelet count < 100,000/μL).
- •History of platelet disorders e.g. von Willebrand factor deficiency, Glanzmann thrombasthenia or Bernard-Soulier syndrome.
- •History of hemophilia or bleeding disorders.
- •Females who are in the last trimester of pregnancy or are breastfeeding.
- •Known active gastrointestinal disease including peptic ulcers, gastro-esophageal reflux disease (GERD), and hyperacidity.
- •Currently participating in a study involving an investigational drug or compound known to affect coagulation or hemostasis.
- •Subjects with significant past medical history as determined by the Investigator that would pose safety concerns or interfere with the study goals.
- •Von Willebrand Disease Subjects
- •Inclusion Criteria:
- •Males and females age 21 years or older.
- •Prior diagnosis of von Willebrand disease type 1, 2A, 2B, 2M, or 3
- •Able and willing to provide written informed consent.
- •Exclusion Criteria:
- •Prior diagnosis of von Willebrand disease type 2N
- •Use of antiplatelet therapy besides aspirin within the past 14 days.
- •Use of anticoagulant drugs within the past 14 days, e.g. heparin, bivalirudin, warfarin, rivaroxaban, and apixaban.
- •Use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) that inhibit COX-1 such as naproxen or ibuprofen within the past 7 days, unless confirmed to not inhibit platelet activity (such as celecoxib).
- •Significant renal dysfunction or dialysis.
- •Known thrombocytopenia (platelet count < 100,000/μL).
- •Currently participating in a study involving an investigational drug or compound known to affect coagulation or hemostasis.
- •Subjects with significant past medical history as determined by the Investigator that would pose safety concerns or interfere with the study goals.
结局指标
主要结局
Method agreement
时间窗: For each enrolled subject, following testing of blood sample with the T-TAS PL assay; data will be compiled and analyzed in aggregate at the time of study completion.
Agreement of PL assay AUC results between the T-TAS wS and T-TAS 01 measurement systems
次要结局
未报告次要终点
研究者
研究点 (2)
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