临床试验/NCT06114641

NCT06114641已完成4 期

Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients

PT Bio Farma3 个研究点分布在 1 个国家目标入组 220 人开始时间: 2023年6月1日最近更新: 2025年6月6日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: PT Bio Farma
入组人数: 220
试验地点: 3
主要终点: The non-inferiority of Ovine Enoxaparin Sodium compared to Originator enoxaparin on the proportion of death, recurrent or refractory angina, and stroke during hospitalization

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of this study is evaluating safety and effectiveness of Ovine Enoxaparin Sodium in Non-ST-Segment Elevation Acute Coronary Syndrome (NSTEACS) Patients

详细描述

To assess the non-inferiority of Ovine Enoxaparin Sodium compared to Originator enoxaparin on the proportion of death, recurrent or refractory angina, and stroke during hospitalization within 10 days.

Effectiveness:

● Number and percentage of subjects with the composite of major adverse cardiac events (MACE) including death, recurrent myocardial infarction, recurrent angina, stroke, and unplanned revascularization after Ovine Enoxaparin Sodium and Originator enoxaparin administration within 30 days post initial administration.

Safety:

Number and percentage of subjects with major bleeding occurring after Ovine Enoxaparin Sodium and Originator enoxaparin administration during hospitalization or maximum within 10 days using BARC scoring system.
Number and percentage of subjects with minor bleeding occurring after Ovine Enoxaparin Sodium and Originator enoxaparin administration during hospitalization or maximum within 10 days using BARC scoring system.
Number and percentage of subjects with thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on day-3 post initial administration.
Number and percentage of subjects with thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on day-6 post initial administration.
Number and percentage of subjects with thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on day-10(+7) post initial administration.
Number and percentage of subjects with thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration at 30(+10) days post initial administration
Number and percentage of subjects with any serious adverse event after Ovine Enoxaparin Sodium and Originator enoxaparin administration during hospitalization or maximum within 10 days.
Number and percentage of subjects with any serious adverse event after Ovine Enoxaparin Sodium and Originator enoxaparin administration within 30(+10) days post initial administration.
Number and percentage of subjects with non-serious adverse events after Ovine Enoxaparin Sodium and Originator enoxaparin administration within 30(+10) days post initial administration.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Subjects with a diagnosis of non-ST-segment Elevation Acute Coronary Syndrome (NSTEACS) (unstable angina pectoris or Non-ST-Segment-Elevation myocardial infarction (NSTEMI)) based on particular diagnosis criteria
•Subjects with a diagnosis of non-ST-segment Elevation Acute Coronary Syndrome (NSTEACS) (unstable angina pectoris or Non-ST-Segment-Elevation myocardial infarction (NSTEMI)) based on particular diagnosis criteria
•Subjects or legally acceptable representatives have been informed properly regarding the study and signed the informed consent form

排除标准

•Subject concomitantly enrolled or scheduled to be enrolled in another study.
•Subjects use any other anticoagulant agent.
•Hemoglobin level below or equal to 9 mg/dl (for male) and 8.5 mg/dl (for female) or active bleeding.
•Any severe hematologic disease or history of intracerebral mass, aneurysm, arteriovenous malformation, recent (<6 months) ischemic stroke or TIA, recent (< 6 months) intracranial hemorrhage or gastrointestinal or genitourinary bleeding within the past 2 weeks.
•History of allergy or hypersensitivity to enoxaparin heparin or its derivatives, including other low molecular weight heparins (LWMH).
•History of Heparin type II-induced thrombocytopenia (HIT).
•Have severe renal failure (Creatinine Clearance below 15 mL/min), acute infectious endocarditis, hemodynamic instability, life threatening arrhythmia and cardiac arrest.
•A recent (<48 hours) or under spinal/epidural anesthesia.
•Platelet count below or equal to 100,000/mm3 at baseline

研究组 & 干预措施

Test Drug

Experimental

Initial dose 30 mg IV loading dose is administered and followed by 1 mg/kg subcutaneously every 12 hours

干预措施: Enoxaparin sodium injection (Drug)

Comparator

Active Comparator

Initial dose 30 mg IV loading dose is administered and followed by 1 mg/kg subcutaneously every 12 hours

干预措施: Enoxaparin sodium injection (Drug)

结局指标

主要结局

The non-inferiority of Ovine Enoxaparin Sodium compared to Originator enoxaparin on the proportion of death, recurrent or refractory angina, and stroke during hospitalization

时间窗: During hospitalization or maximum within 10 days.

Number and precentage non-inferiority of Ovine Enoxaparin Sodium compared to Originator enoxaparin on the proportion of death, recurrent or refractory angina, and stroke during hospitalization

次要结局

The minor bleeding after Ovine Enoxaparin Sodium and Originator enoxaparin administration during hospitalization or maximum within 10 days.(During hospitalization or maximum within 10 days.)
The thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on day-3 post initial administration(Day-3 post initial administration)
The thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on day-6 post initial administration(Day-6 post initial administration)
The thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on day-10(+7) post initial administration(Day-10(+7) post initial administration)
The composite of MACE including death, recurrent myocardial infarction, recurrent angina, stroke, and unplanned revascularization after Ovine Enoxaparin Sodium and Originator enoxaparin administration within 30 days post initial administration.(Within 30 days post initial administration.)
The major bleeding after Ovine Enoxaparin Sodium and Originator enoxaparin administration during hospitalization or maximum within 10 days using BARC scoring system during hospitalization or maximum within 10 days.(During hospitalization or maximum within 10 days.)
The thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on 30(+10) days post initial administration(30(+10) days post initial administration)
Serious adverse event after Ovine Enoxaparin Sodium and Originator enoxaparin administration during hospitalization or maximum within 10 days During hospitalization or maximum within 10 days.(During hospitalization or maximum within 10 days.)
Serious adverse event after Ovine Enoxaparin Sodium and Originator enoxaparin administration on 30(+10) days post initial administration.(30(+10) days post initial administration.)
Non-serious adverse events after Ovine Enoxaparin Sodium and Originator enoxaparin administration within 30(+10) days post initial administration.(30(+10) days post initial administration.)

研究者

发起方

PT Bio Farma

申办方类型

Industry

责任方

Sponsor

研究点 (3)

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