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

Phase 3
18 Years
Not Enrolling
Myocardial Ischemia

Thank you

Trial Information

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

Exclusion Criteria:

- Known or suspected pregnancy or actively breast-feeding

- Female of childbearing potential not using or planning to use a reliable method of

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

during the study conduct

Safety Issue:


Principal Investigator

Stan Glezer

Investigator Role:

Study Director

Investigator Affiliation:



Canada: Health Canada

Study ID:




Start Date:

June 2004

Completion Date:

Related Keywords:

  • Myocardial Ischemia
  • Myocardial Ischemia
  • Coronary Artery Disease
  • Ischemia