Ignite Creation Date:
2024-05-05 @ 11:32 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01356992
Status:
TERMINATED
Last Update Posted:
2015-06-18
First Post:
2011-05-18
Brief Title:
Patients With High-risk Acute Coronary Syndrome Without ST-segment Elevation
Sponsor:
Eurofarma Laboratorios SA
Organization:
Eurofarma Laboratorios SA
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change in strategy regarding the product by the company
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VECOR
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 andor 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 V1V2 or V3V4 or V5V6 or D1AVL or D2D3AVF 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 eg 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 30mlmin 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 investigators opinion Recent participation last 12 months in a clinical study
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 andor 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 V1V2 or V3V4 or V5V6 or D1AVL or D2D3AVF 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 eg 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 30mlmin 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 investigators opinion Recent participation last 12 months in a clinical study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None