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

NCT01356992 | Terminated Phase 3

• 1 other identifier: EF 117
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 5

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.

Conditions

Non ST Segment Elevation Myocardial Infarction; Unstable Angina

Keywords

non-inferiority phase III study; Low-Molecular Weight Heparin; Versa® (enoxaparin - Eurofarma); Clexane® (enoxaparin - Sanofi-Aventis); Acute coronary syndrome without ST-segment elevation

Outcome Measures

Primary Outcomes (1)

• Frequency of death and infarction within 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.

  30 days after the admission in emergency

Secondary Outcomes (1)

• 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

Study Arms (2)

Clexane® (enoxaparin - Sanofi)

ACTIVE COMPARATOR

Drug: Enoxaparin

Versa® (enoxaparin - Eurofarma)

EXPERIMENTAL

Drug: Enoxaparin

Interventions

Enoxaparin 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.

Clexane® (enoxaparin - Sanofi); Versa® (enoxaparin - Eurofarma)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (5)

Unknown Facility

Salvador, Estado de Bahia, Brazil

Location

Unknown Facility

Belo Horizonte, Minas Gerais, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, Brazil

Location

Unknown Facility

São Jose Do Rio Preto, São Paulo, Brazil

Location

Unknown Facility

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Angina, Unstable

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 20, 2011
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 18, 2015

Record last verified: 2015-06

Locations

BR (5)