FOCUS:Focus On Coronary Unstable Syndromes

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 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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia
• Intervention / Treatment: Drug: Ramipril

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the highly specific C-reactive protein (hsCRP) blood levels	during the study conduct
To assess the tumor necrosing factor alpha (TNFα) blood levels	during the study conduct

Secondary Outcome Measures

Outcome Measure	Time Frame
TEAEs collection	From the signature of the informed consent up to the end of the study

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Stan Glezer, Sanofi

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): July 1, 2005

Study Registration Dates

• First Submitted: December 21, 2005
• First Submitted That Met QC Criteria: December 21, 2005
• First Posted (Estimate): December 22, 2005

Study Record Updates

• Last Update Posted (Estimate): January 11, 2011
• Last Update Submitted That Met QC Criteria: January 10, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia; Ischemia; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Ramipril
• Other Study ID Numbers: HOE498_3501