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

Unstable Angina Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01356992
• Other study ID #: EF 117
• Status: Terminated
• Phase: Phase 3
• First received: May 18, 2011
• Last updated: June 17, 2015
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: June 2015
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Myocardial Infarction
• Non ST Segment Elevation Myocardial Infarction
• Unstable Angina

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	30 days after the admission in emergency	Yes