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FOCUS:Focus On Coronary Unstable Syndromes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00268619
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : January 11, 2011
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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.

Condition or disease Intervention/treatment Phase
Myocardial Ischemia Drug: Ramipril Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : June 2004
Actual Primary Completion Date : July 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Ramipril

Primary Outcome Measures :
  1. To assess the highly specific C-reactive protein (hsCRP) blood levels [ Time Frame: during the study conduct ]
  2. To assess the tumor necrosing factor alpha (TNFα) blood levels [ Time Frame: during the study conduct ]

Secondary Outcome Measures :
  1. TEAEs collection [ Time Frame: From the signature of the informed consent up to the end of the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00268619

Sponsors and Collaborators
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Study Director: Stan Glezer Sanofi

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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00268619     History of Changes
Other Study ID Numbers: HOE498_3501
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents