A Study of the Transition From Cangrelor to Clopidogrel or Prasugrel in Patients With Coronary Artery Disease.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Extent Of Preservation Of Platelet Inhibitory Effect Of Cangrelor Treatment After Prasugrel Or Clopidogrel Compared To Treatment With Cangrelor Alone
研究概览
简要总结
There are two separate objectives in this study:
- To demonstrate the pharmacodynamic (PD) profile when participants treated with cangrelor are switched to oral prasugrel 60 mg administered 30 minutes (min) after cangrelor infusion is discontinued
- To demonstrate the PD profile when participants treated with cangrelor are switched to oral clopidogrel 600 mg administered during or immediately after cangrelor infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than or equal to 18 and less than 75 years of age, of either sex, and of any race.
- •Stable CAD 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 or coronary artery bypass graft, and
- •Treatment with aspirin 81 mg daily.
排除标准
- •Known intolerance or contraindication to cangrelor or prasugrel, or any ingredients of the respective formulation.
- •Any antiplatelet (other than aspirin) or anticoagulant medication within the previous 30 days.
- •Acute coronary syndrome within the previous 12 months.
- •History of bleeding diathesis or known coagulopathy such as; impaired hemostasis; known international normalized ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders, such as, von Willebrand's disease or hemophilia), acquired bleeding disorders, and unexplained clinically significant bleeding disorders; thrombocytopenia (platelet count less than 100,000/microliter [µL]), or history of thrombocytopenia or neutropenia associated with clopidogrel.
- •Anemia (for example, hematocrit less than 35%).
- •Prior stroke (any type), prior cerebral arteriovenous malformation or intracranial aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery).
- •Known or suspected pregnancy, or lactating females.
- •Known severe renal insufficiency (glomerular filtration rate less than 30 milliliter [mL]/min).
- •Inability to provide informed consent.
- •Moderate or severe hepatic impairment as per Investigator's discretion (elevation of liver function tests).
- •Inability to swallow oral medication at time of randomization.
- •Any clinically significant disease or condition affecting a major organ system, including but not limited to gastrointestinal, renal, hepatic, endocrinologic, broncho-pulmonary, neurological, or metabolic disease.
- •Any surgical or medical condition which, in the judgment of the Investigator, might interfere with the pharmacokinetics, distribution, metabolism, or excretion of the study drug (if applicable).
- •Treatment with other investigational medicinal products or devices within 30 days or 5 half-lives, whichever is longer, prior to the administration of the drug, or planned use of investigational medicinal products or devices.
- •Participants who, for any reason, are deemed by the Investigator to be inappropriate for this study, including participants who are unable to communicate or to cooperate with the Investigator.
- •Participant is the Investigator or his/her deputy, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
- •Active pathological bleeding, or a history of transient ischemic attack.
研究组 & 干预措施
Clopidogrel 1 Hr During Cangrelor
Clopidogrel 600 mg administered orally 1 hr after the initiation of cangrelor infusion on Day 1.
干预措施: Cangrelor (Drug)
Clopidogrel 1 Hr During Cangrelor
Clopidogrel 600 mg administered orally 1 hr after the initiation of cangrelor infusion on Day 1.
干预措施: Clopidogrel (Drug)
Prasugrel 30 Min After Cangrelor
Prasugrel 60 milligram (mg) administered orally 30 min after the discontinuation of cangrelor infusion on Day 1 (2.5 hours [hrs] after initiation of cangrelor infusion).
干预措施: Cangrelor (Drug)
Prasugrel 30 Min After Cangrelor
Prasugrel 60 milligram (mg) administered orally 30 min after the discontinuation of cangrelor infusion on Day 1 (2.5 hours [hrs] after initiation of cangrelor infusion).
干预措施: Prasugrel (Drug)
Clopidogrel Within 5 Min After Cangrelor
Clopidogrel 600 mg administered orally within 5 min after the discontinuation of the cangrelor infusion on Day 1 (2 hrs after initiation of cangrelor infusion).
干预措施: Cangrelor (Drug)
Clopidogrel Within 5 Min After Cangrelor
Clopidogrel 600 mg administered orally within 5 min after the discontinuation of the cangrelor infusion on Day 1 (2 hrs after initiation of cangrelor infusion).
干预措施: Clopidogrel (Drug)
Clopidogrel 1.5 Hrs During Cangrelor
Clopidogrel 600 mg administered orally 1.5 hrs after the initiation of cangrelor infusion on Day 1.
干预措施: Cangrelor (Drug)
Clopidogrel 1.5 Hrs During Cangrelor
Clopidogrel 600 mg administered orally 1.5 hrs after the initiation of cangrelor infusion on Day 1.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Extent Of Preservation Of Platelet Inhibitory Effect Of Cangrelor Treatment After Prasugrel Or Clopidogrel Compared To Treatment With Cangrelor Alone
时间窗: Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion
A reference point for cangrelor was chosen for comparison and designated as the administration time of prasugrel 60 mg or clopidogrel 600 mg (2.5, 2, 1.5, or 1 hrs). Platelet function was assessed using LTA. LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was examined using LTA and expressed as % aggregation in response to 20 μM ADP at 300 sec (final/terminal aggregation response).
Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone
时间窗: Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion
A reference point for prasugrel or clopidogrel was chosen for comparison and designated at 6 or 5.5 hrs after the administration of prasugrel or clopidogrel as the reference for the effect of the oral drug. Platelet function was assessed using light transmittance aggregometry (LTA). LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (sec) (final/terminal aggregation response).
次要结局
- Bleeding Events In Accordance With GUSTO Scale(Screening through the follow-up period (5 to 7 days after Day 1))
- Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor to Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Determined By VerifyNow P2Y12 Assay(Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion)
- Extent of Preservation of Platelet Inhibitory Effect of Cangrelor Treatment After Prasugrel or Clopidogrel Compared to Treatment With Cangrelor Alone Determined By VerifyNow P2Y12 Assay(Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion)