A Study of the Transition From IV Cangrelor to Oral Prasugrel, and Prasugrel to Cangrelor, in Patients With Coronary Artery Disease.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
研究概览
简要总结
To demonstrate that patients treated with cangrelor can be directly switched to oral prasugrel and that patients treated with prasugrel can be switched to cangrelor without a significant decrease in the extent of inhibition of platelet aggregation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •greater than / equal to 18 and less than 75 years of age
- •stable coronary artery disease defined by the following criteria
- •Previous myocardial infarction defined by admission to the hospital with elevation of markers of injury or the presence of pathologic Q waves on at least 2 contiguous electrocardiogram (ECG) leads.
- •Previous revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG).
- •Treatment with aspirin (ASA) 81 mg daily.
排除标准
- 未提供
研究组 & 干预措施
Day 1 - Cangrelor + Prasugrel (60mg) post infusion
Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation
干预措施: Cangrelor (Drug)
Day 1 - Cangrelor + Prasugrel (60mg) post infusion
Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation
干预措施: Prasugrel (Drug)
Day 8 - Prasugrel (10mg) Dosing (5 doses)
Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h)
干预措施: Cangrelor (Drug)
Day 8 - Prasugrel (10mg) Dosing (5 doses)
Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h)
干预措施: Prasugrel (Drug)
Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h
Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time.
干预措施: Cangrelor (Drug)
Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h
Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time.
干预措施: Prasugrel (Drug)
Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h
Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time.
干预措施: Cangrelor (Drug)
Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h
Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time.
干预措施: Prasugrel (Drug)
Day 8 - Prasugrel (10mg) Dosing (6 doses)
Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)
干预措施: Cangrelor (Drug)
Day 8 - Prasugrel (10mg) Dosing (6 doses)
Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)
干预措施: Prasugrel (Drug)
结局指标
主要结局
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
时间窗: Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.
A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence or absence of the study drugs was examined for each of the endpoints using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).
Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone
时间窗: Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion
A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 μM adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).
次要结局
- Bleeding Events in Accordance With the GUSTO Scale(Day 1 through Day 8)
- Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)(Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.)
- Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone(Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion)