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FOCUS:Focus On Coronary Unstable Syndromes

Primary Purpose

Myocardial Ischemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ramipril
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Ischemia

Eligibility Criteria

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

Inclusion Criteria: Subject either not of childbearing potential or is not pregnant and agrees to use contraceptive measure for the duration of the study Subjects presenting within 12 hours after the last episode of chest pain with: An accelerating pattern of anginal pain A prolonged or recurrent anginal pain at rest or with minimal effort AND Evidence of myocardial ischemia on ECG manifested by at least one of the following ECG criteria: - new persistent or transient ST-segment depression OR transient or reversible ST-segment elevation or new persistent or transient T-wave inversion OR Abnormal cardiac markers defined as: CK-MB greater than the upper limit of normal Troponin T or I level greater than the upper limit of normal. Exclusion Criteria: Known or suspected pregnancy or actively breast-feeding Female of childbearing potential not using or planning to use a reliable method of contraception Treatment with Hormone Replacement Therapy at time of randomization Angina precipitated by obvious provoking factors Heart Failure defined as known ejection fraction less or equal to 40% or NYHA (New York Heart Association) class III pr IV Type I Diabetes Mellitus Type II diabetes requiring insulin therapy Hyperkaliemia Acute chronic inflammatory, collagen tissue disease, auto-immune disease or cancer and/or requiring the use of anti-inflammatory or anti-neoplastic agents at the time of randomization Use of a non-steriodal anti-inflammatory agent, coxibs, or anti-neoplasic agent within last 7 days Use of any oral or intra-venous steroidal agent in the last 7 days before study entry Uncontrolled hypertension Systolic pressure < 100 mmHg at randomization Likelihood of requiring treatment during the study period with drugs not permitted by the protocol Treatment with any investigational product or device in the last 4 weeks Previous participation into the trial History of hypersensitivity, allergy, or intolerance to Angiotensin-Converting Enzyme inhibitors. Severe cardiovascular diseases requiring urgent therapy Severe or co-morbid condition History of cancer not known to be disease free, with the exception of basal cell carcinoma of the skin Clinically important systemic disorder Impaired hepatic function Clinically important chronic or acute renal failure History of drug or alcohol abuse

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To assess the highly specific C-reactive protein (hsCRP) blood levels
    To assess the tumor necrosing factor alpha (TNFα) blood levels

    Secondary Outcome Measures

    TEAEs collection

    Full Information

    First Posted
    December 21, 2005
    Last Updated
    January 10, 2011
    Sponsor
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00268619
    Brief Title
    FOCUS:Focus On Coronary Unstable Syndromes
    Official Title
    A Placebo-controlled, Double-blind, Randomized, Multicenter Study of Ramipril 5 and 10 mg Capsules and Insulin Infusion in Subjects With Unstable Coronary Syndromes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    July 2005 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sanofi

    4. Oversight

    5. Study Description

    Brief Summary
    Study objectives: To demonstrate that the acute administration of ramipril will control the inflammation process in patients with high-risk Acute Coronary Syndrome (ACS) as assessed by the high sensitivity C-reactive protein blood levels. To demonstrate that the normalization of blood glucose levels with intravenous insulin will improve the inflammation process during the acute phase of an ACS as assessed by Tumor necrosis factor alpha blood levels.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Ramipril
    Primary Outcome Measure Information:
    Title
    To assess the highly specific C-reactive protein (hsCRP) blood levels
    Time Frame
    during the study conduct
    Title
    To assess the tumor necrosing factor alpha (TNFα) blood levels
    Time Frame
    during the study conduct
    Secondary Outcome Measure Information:
    Title
    TEAEs collection
    Time Frame
    From the signature of the informed consent up to the end of the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject either not of childbearing potential or is not pregnant and agrees to use contraceptive measure for the duration of the study Subjects presenting within 12 hours after the last episode of chest pain with: An accelerating pattern of anginal pain A prolonged or recurrent anginal pain at rest or with minimal effort AND Evidence of myocardial ischemia on ECG manifested by at least one of the following ECG criteria: - new persistent or transient ST-segment depression OR transient or reversible ST-segment elevation or new persistent or transient T-wave inversion OR Abnormal cardiac markers defined as: CK-MB greater than the upper limit of normal Troponin T or I level greater than the upper limit of normal. Exclusion Criteria: Known or suspected pregnancy or actively breast-feeding Female of childbearing potential not using or planning to use a reliable method of contraception Treatment with Hormone Replacement Therapy at time of randomization Angina precipitated by obvious provoking factors Heart Failure defined as known ejection fraction less or equal to 40% or NYHA (New York Heart Association) class III pr IV Type I Diabetes Mellitus Type II diabetes requiring insulin therapy Hyperkaliemia Acute chronic inflammatory, collagen tissue disease, auto-immune disease or cancer and/or requiring the use of anti-inflammatory or anti-neoplastic agents at the time of randomization Use of a non-steriodal anti-inflammatory agent, coxibs, or anti-neoplasic agent within last 7 days Use of any oral or intra-venous steroidal agent in the last 7 days before study entry Uncontrolled hypertension Systolic pressure < 100 mmHg at randomization Likelihood of requiring treatment during the study period with drugs not permitted by the protocol Treatment with any investigational product or device in the last 4 weeks Previous participation into the trial History of hypersensitivity, allergy, or intolerance to Angiotensin-Converting Enzyme inhibitors. Severe cardiovascular diseases requiring urgent therapy Severe or co-morbid condition History of cancer not known to be disease free, with the exception of basal cell carcinoma of the skin Clinically important systemic disorder Impaired hepatic function Clinically important chronic or acute renal failure History of drug or alcohol abuse
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stan Glezer
    Organizational Affiliation
    Sanofi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    FOCUS:Focus On Coronary Unstable Syndromes

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