A Multicenter, Randomized, Open-label, Non-inferiority Phase III Study, Between Low-Molecular Weight Heparins, Versa® (Enoxaparin - Eurofarma) and Clexane® (Enoxaparin - Sanofi-Aventis), in Patients With High-risk Acute Coronary Syndrome Without ST-segment Elevation.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 主要终点
- Frequency of death and infarction within 30 days after the admission in emergency
研究概览
简要总结
This non-inferiority study aims at comparing Versa® to the reference enoxaparin (Clexane®, Sanofi-Aventis) in patients with high-risk unstable angina and NSTEMI. The main justification is the search for scientific evidence to prove the Versa® effectiveness for this new therapeutic indication, since it is a product with potential for reducing costs, with effectiveness and safety comparable to the reference drug.
详细描述
To be included in this study, the eligible patients must meet all criteria below:
IC signature; The research subject must agree about following all instructions and perform the procedures and study visits; Men and women over the age of 18 and below the age of 75; History of angina of rest with a minimum duration of 20 minutes in the last 24 hours at the beginning and at least for 10 days.
Patient Randomization up to 6 hours after the arrival at the emergency sector.
Evidence of NSTEMI or unstable angina due to one or more of the following criteria:
- Dynamic alterations on the T-wave (ST-segment depression or elevation > 1 mm, and/or T-wave inversions which are solved at least partially when the symptoms are relieved) or 2. Unevenly ST-segment (depression or elevation) in a transitional way under continuous derivations (V1+V2 or V3+V4 or V5+V6 or D1+AVL or D2+D3+AVF) or 3. Biochemical alteration on the myocardial necrosis markers (CKMB mass, troponin T or I and CPK), with the appearance of enzymatic curve, characterizing myocardial injury or 5. Pulmonary Edema; or 6. Angina associated to murmur of mitral regurgitation; or 7. Angina with heart sound to cardiac auscultation or throes; or 8. Angina with hypotension;
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICF signature;
- •The research subject must agree about following all instructions and perform the procedures and study visits;
- •Men and women over the age of 18 and below the age of 75;
- •History of angina of rest with a minimum duration of 20 minutes in the last 24 hours at the beginning and at least for 10 days.
- •Patient Randomization up to 6 hours after the arrival at the emergency sector.
- •Evidence of NSTEMI or unstable angina due to one or more of the following criteria:
- •Dynamic alterations on the T-wave (ST-segment depression or elevation > 1 mm, and/or T-wave inversions which are solved at least partially when the symptoms are relieved) or
- •Unevenly ST-segment (depression or elevation) in a transitional way under continuous derivations (V1+V2 or V3+V4 or V5+V6 or D1+AVL or D2+D3+AVF) or
- •Biochemical alteration on the myocardial necrosis markers (CKMB mass, troponin T or I and CPK), with the appearance of enzymatic curve, characterizing myocardial injury or
- •Pulmonary Edema; or
- •Angina associated to murmur of mitral regurgitation; or
- •Angina with heart sound to cardiac auscultation or throes; or
- •Angina with hypotension;
排除标准
- •12-derivation-ECG with persistent ST-segment elevation;
- •Diagnosis of angina by secondary cause (e.g., anemia, fever, hypovolemia, dehydration, use of cocaine);
- •Use of non-fractionated heparin or low-molecular weight heparin in the prior 48 to the randomization;
- •Concomitant diseases, such as severe renal failure (creatinine clearance lower than 30ml/min.) and hepatic, or other significant comorbidities under investigator judgment;
- •Recent hemorrhagic cerebrovascular accident (last 12 months);
- •Patient scheduled for cardiac surgery of myocardial revascularization;
- •Use of drugs, alcohol abuse;
- •Pregnancy or lactation;
- •Recent neurosurgery or ophthalmic surgery (last 3 months);
- •History or diagnosis of coagulopathy;
- •Medical record containing allergy, hypersensibility or intolerance to any of the drug components to be used on this study, which is judged as clinically significant in the main investigator's opinion;
- •Recent participation (last 12 months) in a clinical study.
研究组 & 干预措施
Clexane® (enoxaparin - Sanofi)
干预措施: Enoxaparin (Drug)
Versa® (enoxaparin - Eurofarma)
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Frequency of death and infarction within 30 days after the admission in emergency
时间窗: 30 days after the admission in emergency
The study primary objective aims at evaluating the enoparaxin sodium (Eurofarma) effectiveness and safety on the treatment of patients with NSTE-ACS and high-risk ones, regarding the Sanofi-Aventis enoxaparin sodium. The primary endpoint will be the frequency of death and infarction within 30 days after the admission in emergency.
次要结局
- Comparing the effectiveness and safety of the two formulations in patients with NSTE-ACS and high-risk ones(30 days after the admission in emergency)