FOCUS:Focus On Coronary Unstable Syndromes

NCT00268619 | Completed Phase 3

• 1 other identifier: HOE498_3501
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• TEAEs collection

  From the signature of the informed consent up to the end of the study

Interventions

Ramipril DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Stan Glezer

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 21, 2005
• First Posted: December 22, 2005
• Study Start: June 1, 2004
• Primary Completion: July 1, 2005
• Last Updated: January 11, 2011

Record last verified: 2011-01