patients with high-risk acute coronary syndrome without st-segment elevation

Conditions: Non ST Segment Elevation Myocardial Infarction; Unstable Angina

Summary: 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.

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: 1. 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; the patients who meet anyone of the criteria below will not be eligible for the study: 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.

Eligibility criteria:
inclusion criteria: * 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: 1. 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; exclusion criteria: * 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.

Keywords: non-inferiority phase iii study low-molecular weight heparin versa® (enoxaparin - eurofarma) clexane® (enoxaparin - sanofi-aventis) acute coronary syndrome without st-segment elevation