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CompletedNCT00268619Updated Jan 11, 2011

FOCUS:Focus On Coronary Unstable Syndromes

A Phase 3 interventional study of Ramipril in Myocardial Ischemia, sponsored by Sanofi. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-11.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Myocardial Ischemia

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03

In context

Myocardial Ischemia

3,233 studies on the registry are indexed under Myocardial Ischemia; 396 are open to participants now.

Browse Myocardial Ischemia studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double

Interventions

  • DrugRamipril
06

What researchers measure

Primary outcomes

  1. To assess the highly specific C-reactive protein (hsCRP) blood levels

    Time frame: during the study conduct

  2. To assess the tumor necrosing factor alpha (TNFα) blood levels

    Time frame: during the study conduct

Secondary outcomes

  1. TEAEs collection

    Time frame: From the signature of the informed consent up to the end of the study

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00268619
Lead sponsor
Sanofi
First posted
Dec 22, 2005
Start date
Jun 2004
Primary completion
Jul 2005
Last update
Jan 11, 2011

Study contacts

Stan Glezer
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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