Non ST Segment Elevation Myocardial InfarctionPhase 3VECORNCT01356992

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

A Phase 3 study testing Enoxaparin in people with Non ST Segment Elevation Myocardial Infarction and Unstable Angina, run by Eurofarma Laboratorios S.A. at 5 sites in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non ST Segment Elevation Myocardial Infarction, Unstable Angina
What is being tested?: Enoxaparin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 5 sitesBrazil
Study dates: Jul 2012to Jul 2013
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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;

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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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Brazil5 sites

Study site
Belo Horizonte, Minas Gerais
Study site
Porto Alegre, Rio Grande do Sul
Study site
Salvador, Estado de Bahia
Study site
São Jose Do Rio Preto, São Paulo
Study site
São Paulo, São Paulo

Other trials in Brazil

About this study

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.

Read the 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:

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
Being tested: Enoxaparin
Keywords: non-inferiority phase III study, Low-Molecular Weight Heparin, Versa® (enoxaparin - Eurofarma), Clexane® (enoxaparin - Sanofi-Aventis), Acute coronary syndrome without ST-segment elevation
Medical subject headings: Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EnoxaparinDrug
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.

Study groups in NCT01356992
Study group	Role	What they receive
Clexane® (enoxaparin - Sanofi)	Active comparator	Not described Receives: Drug: Enoxaparin
Versa® (enoxaparin - Eurofarma)	Experimental	Not described Receives: Drug: Enoxaparin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 30 days after the admission in emergency

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Jul 2013

First posted20 May 2011 (estimated)
Study startJul 2012
Primary completionJul 2013
Study completionJul 2013

Why it stopped: Change in strategy regarding the product by the company

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non ST Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01356992
Sponsor's protocol ID: EF 117
Acronym: VECOR
Status last verified: Jun 2015
First submitted: 18 May 2011
Last updated: 18 Jun 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non ST Segment Elevation Myocardial Infarction trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT01356992
Acronym / sponsor ID: VECOR / EF 117
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
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Change in strategy regarding the product by the company
Enrolment: 62 participants (actual)
Lead sponsor: Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 20 May 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

To be included in this study, the eligible patients must meet all criteria below:

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;

The patients who meet anyone of the criteria below will not be eligible for the study:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Clexane® (enoxaparin - Sanofi)	Active comparator	Drug: Enoxaparin
Versa® (enoxaparin - Eurofarma)	Experimental	Drug: Enoxaparin

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (12 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EnoxaparinDrugs 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.	Drug	Clexane® (enoxaparin - Sanofi), Versa® (enoxaparin - Eurofarma)

Primary outcome

Frequency of death and infarction within 30 days after the admission in emergency
Time frame: 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.

1 secondary outcome

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

Results and safety

The study was stopped early (reason given: Change in strategy regarding the product by the company). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.

Related trials for Non ST Segment Elevation Myocardial Infarction

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Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enoxaparin in people with Non ST Segment Elevation Myocardial Infarction and Unstable Angina, run by Eurofarma Laboratorios S.A. at 5 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Change in strategy regarding the product by the company). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of death and infarction within 30 days after the admission in emergency (time frame: 30 days after the admission in emergency). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01356992.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2015.