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

NCT ID: NCT01356992

Last Updated: 2015-06-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-07-31

Brief 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.

Detailed Description

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.

Conditions

Non ST Segment Elevation Myocardial Infarction; Unstable Angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clexane® (enoxaparin - Sanofi)

Group Type: ACTIVE_COMPARATOR

Enoxaparin

Intervention Type: DRUG

Drugs will be provided by the sponsor to the study's patients on the reference presentation: 40 mg/0.4mL, 60 mg/0.6 mL and 80 mg/0.8 mL (solution for injection of enoxaparin sodium, 1 mg/ kg Sanofi-Aventis) or Eurofarma enoxaparin sodium (1 mg/ kg). The patients will use the drug corresponding to the arm of the study to which they were allocated. The drug administration must be performed through subcutaneous via on the dose of 1 mg/kg every 12 hours for at least 2 days and kept until the patient is discharged.

Versa® (enoxaparin - Eurofarma)

Group Type: EXPERIMENTAL

Enoxaparin

Intervention Type: DRUG

Drugs will be provided by the sponsor to the study's patients on the reference presentation: 40 mg/0.4mL, 60 mg/0.6 mL and 80 mg/0.8 mL (solution for injection of enoxaparin sodium, 1 mg/ kg Sanofi-Aventis) or Eurofarma enoxaparin sodium (1 mg/ kg). The patients will use the drug corresponding to the arm of the study to which they were allocated. The drug administration must be performed through subcutaneous via on the dose of 1 mg/kg every 12 hours for at least 2 days and kept until the patient is discharged.

Interventions

Enoxaparin

Drugs will be provided by the sponsor to the study's patients on the reference presentation: 40 mg/0.4mL, 60 mg/0.6 mL and 80 mg/0.8 mL (solution for injection of enoxaparin sodium, 1 mg/ kg Sanofi-Aventis) or Eurofarma enoxaparin sodium (1 mg/ kg). The patients will use the drug corresponding to the arm of the study to which they were allocated. The drug administration must be performed through subcutaneous via on the dose of 1 mg/kg every 12 hours for at least 2 days and kept until the patient is discharged.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Salvador, Estado de Bahia, Brazil

Belo Horizonte, Minas Gerais, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

São Jose Do Rio Preto, São Paulo, Brazil

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EF 117

Identifier Type: -

Identifier Source: org_study_id