計劃書編號EFC 10295
2007-12-01 - 2012-12-31
Phase III
終止收納3
ICD-10I48.0
陣發性心房顫動
ICD-10I48.2
慢性心房顫動
ICD-10I48.91
心房顫動
ICD-9427.31
心房顫動
多中心、隨機、雙盲、評估者盲性，不劣於對照組的研究，針對心房顫動的患者，給予biotinylated idraparinux (SSR126517E) 每週皮下注射一次，同時併用調整過劑量的口服warfarin，以評估其預防中風及全身性血栓栓塞事件的療效及安全性
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試驗申請者
賽諾菲股份有限公司
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試驗委託 / 贊助單位名稱
賽諾菲股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2025/08/20
試驗主持人及試驗醫院
適應症
ATRIAL FIBRILLATION
試驗目的
The objective of this study is to evaluate wether the new investigational, neutralizable blood thinner (anticoagulant) "biotinylated idraparinux", administered once weekly under the skin, is at least as efficient to prevent clots in brain and in the other organs than the standard of care with warfarin an oral anticoagulant whose doses are adjusted according to a regular monitoring of a blood coagulation test (INR) in patients with heart rhythm disorder called "atrial fibrillation".
藥品名稱
idraparinux
主成份
Avidin
biotinylated idraparinux
biotinylated idraparinux
劑型
IV infusion
皮下注射
皮下注射
劑量
105
6 mg
6 mg
評估指標
主要療效指標為在預計的治療期間內，經由中央獨立仲裁
委員會確認發生的所有中風（缺血性、出血性或未加以定
義者）及非中樞神經系統之全身性栓塞個案的綜合結果。
重要的次要指標為在預計的治療期間內發生的所有中風、
非中樞神經系統之全身性栓塞、心肌梗塞、大型出血（根
據中央獨立仲裁委員會之分類）及死亡個案的綜合結果。
委員會確認發生的所有中風（缺血性、出血性或未加以定
義者）及非中樞神經系統之全身性栓塞個案的綜合結果。
重要的次要指標為在預計的治療期間內發生的所有中風、
非中樞神經系統之全身性栓塞、心肌梗塞、大型出血（根
據中央獨立仲裁委員會之分類）及死亡個案的綜合結果。
主要納入條件
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Non valvular atrial fibrillation (AF)
Indication for long-term Vitamin-K antagonist (VKA) therapy based on the presence of previous ischemic stroke, transient ischemic attack or systemic embolism and/or at least two of the following risk factors: hypertension requiring drug treatment, moderately or severly impaired left ventricular function and/or congestive heart failure, age > 75 years, diabetes mellitus.
Exclusion Criteria:
Indication for VKA other than AF
Stroke or Transient Ischemic Attack within previous 5 days
Transient atrial fibrillation caused by a reversible disorder
Planned major surgery/trauma or cardioversion within 30 days
INR > 3 at baseline
Active bleeding or high risk of bleeding
Uncontrolled hypertension
Pregnant or childbearing potential without proper contraceptive measures or breast feeding.
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Non valvular atrial fibrillation (AF)
Indication for long-term Vitamin-K antagonist (VKA) therapy based on the presence of previous ischemic stroke, transient ischemic attack or systemic embolism and/or at least two of the following risk factors: hypertension requiring drug treatment, moderately or severly impaired left ventricular function and/or congestive heart failure, age > 75 years, diabetes mellitus.
Exclusion Criteria:
Indication for VKA other than AF
Stroke or Transient Ischemic Attack within previous 5 days
Transient atrial fibrillation caused by a reversible disorder
Planned major surgery/trauma or cardioversion within 30 days
INR > 3 at baseline
Active bleeding or high risk of bleeding
Uncontrolled hypertension
Pregnant or childbearing potential without proper contraceptive measures or breast feeding.
試驗計畫預計收納受試者人數
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台灣人數
70 人
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全球人數
9600 人
