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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Eurofarma Laboratorios S.A..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01356992
First received: May 18, 2011
Last updated: October 4, 2012
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Non ST Segment Elevation Myocardial Infarction
Unstable Angina
Drug: Enoxaparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-label, Non-inferiority Phase III Study, Between Low-Molecular Weight Heparins, Versa® (Enoxaparin - Eurofarma) and Clexane® (Enoxaparin - Sanofi-Aventis), in Patients With High-risk Acute Coronary Syndrome Without ST-segment Elevation.

Resource links provided by NLM:


Further study details as provided by Eurofarma Laboratorios S.A.:

Primary Outcome Measures:
  • Frequency of death and infarction within 30 days after the admission in emergency [ Time Frame: 30 days after the admission in emergency ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Comparing the effectiveness and safety of the two formulations in patients with NSTE-ACS and high-risk ones [ Time Frame: 30 days after the admission in emergency ] [ Designated as safety issue: Yes ]

    The secondary endpoints considered for the study are:

    Negative endpoints associated to ACS (shock, pulmonary congestion, arrhythmias, congestive heart failure, hemodynamic instability and reinfarction) during 30 days after the beginning of the treatment.

    Frequency of coronary angioplasty or surgical revascularization procedures; Rate of major bleeding during hospitalization according to TIMI criteria ; Incidence of hemotransfusion in the 30 days after the inclusion on the study.



Estimated Enrollment: 502
Study Start Date: July 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clexane® (enoxaparin - Sanofi) Drug: 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.
Experimental: Versa® (enoxaparin - Eurofarma) Drug: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356992

Contacts
Contact: Camille R Silva, M.D. 5511 41449662 camille.rodrigues@eurofarma.com.br
Contact: Cassiano R Berto, Pharm D 55 11 4144 9681 cassiano.berto@eurofarma.com.br

Locations
Brazil
Recruiting
Salvador, Bahia, Brazil
Recruiting
Belo Horizonte, Minas Gerais, Brazil
Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
São Jose do Rio Preto, São Paulo, Brazil
Not yet recruiting
São Paulo, Brazil
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
  More Information

No publications provided

Responsible Party: Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier: NCT01356992     History of Changes
Other Study ID Numbers: EF 117
Study First Received: May 18, 2011
Last Updated: October 4, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Eurofarma Laboratorios S.A.:
non-inferiority phase III study
Low-Molecular Weight Heparin
Versa® (enoxaparin - Eurofarma)
Clexane® (enoxaparin - Sanofi-Aventis)
Acute coronary syndrome without ST-segment elevation

Additional relevant MeSH terms:
Angina, Unstable
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis
Heparin, Low-Molecular-Weight
Dalteparin
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014