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

Primary Purpose

Non ST Segment Elevation Myocardial Infarction, Unstable Angina

Status
Terminated
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Enoxaparin
Sponsored by
Eurofarma Laboratorios S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non ST Segment Elevation Myocardial Infarction focused on measuring non-inferiority phase III study, Low-Molecular Weight Heparin, Versa® (enoxaparin - Eurofarma), Clexane® (enoxaparin - Sanofi-Aventis), Acute coronary syndrome without ST-segment elevation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Clexane® (enoxaparin - Sanofi)

Versa® (enoxaparin - Eurofarma)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Comparing the effectiveness and safety of the two formulations in patients with NSTE-ACS and high-risk ones
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.

Full Information

First Posted
May 18, 2011
Last Updated
June 17, 2015
Sponsor
Eurofarma Laboratorios S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01356992
Brief Title
Patients With High-risk Acute Coronary Syndrome Without ST-segment Elevation
Acronym
VECOR
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Change in strategy regarding the product by the company
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurofarma Laboratorios S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clexane® (enoxaparin - Sanofi)
Arm Type
Active Comparator
Arm Title
Versa® (enoxaparin - Eurofarma)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of death and infarction within 30 days after the admission in emergency
Description
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.
Time Frame
30 days after the admission in emergency
Secondary Outcome Measure Information:
Title
Comparing the effectiveness and safety of the two formulations in patients with NSTE-ACS and high-risk ones
Description
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.
Time Frame
30 days after the admission in emergency

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
City
Salvador
State/Province
Bahia
Country
Brazil
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
City
São Jose do Rio Preto
State/Province
São Paulo
Country
Brazil
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

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

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