A Placebo-controlled, Double-blind, Randomized, Multicenter Study of Ramipril 5 and 10 mg Capsules and Insulin Infusion in Subjects With Unstable Coronary Syndromes
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