- 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.
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
