FOCUS:Focus On Coronary Unstable Syndromes - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00268619

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 III

Drug Information available for: Ramipril

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

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

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

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Stan Glezer

Sanofi-Aventis

More Information

Additional Information:

CSR synopsis posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	HOE498/3501
Study First Received:	December 21, 2005
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00268619 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Agents

Ischemia
Antihypertensive Agents
Ramipril
Insulin
Protease Inhibitors

Additional relevant MeSH terms:

Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Ischemia
Antihypertensive Agents

Ramipril
Pharmacologic Actions
Protease Inhibitors
Pathologic Processes
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009