FOCUS:Focus On Coronary Unstable Syndromes - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 21, 2005

Last Updated Date

July 28, 2008

Start Date ^†

June 2004

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00268619 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Myocardial Ischemia

Intervention ^†

Drug: Ramipril

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

July 2005 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00268619

Responsible Party

Medical Affairs Study Director, sanofi-aventis

Secondary IDs ^††

Study Sponsor ^†

Sanofi-Aventis

Collaborators ^††

Investigators ^†

Study Director:

Stan Glezer

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

July 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.