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FOCUS:Focus On Coronary Unstable Syndromes

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00268619
First received: December 21, 2005
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Myocardial Ischemia
Drug: Ramipril
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To assess the highly specific C-reactive protein (hsCRP) blood levels [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
  • To assess the tumor necrosing factor alpha (TNFα) blood levels [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TEAEs collection [ Time Frame: From the signature of the informed consent up to the end of the study ] [ Designated as safety issue: No ]

Study Start Date: June 2004
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268619

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Stan Glezer Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00268619     History of Changes
Other Study ID Numbers: HOE498_3501
Study First Received: December 21, 2005
Last Updated: January 10, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Vascular Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014