Overview

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.