Patients With High-risk Acute Coronary Syndrome Without ST-segment Elevation

• Status: Terminated
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Dalteparin; Enoxaparin; Heparin; Heparin, Low-Molecular-Weight

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.