Status:
COMPLETED
FOCUS:Focus On Coronary Unstable Syndromes
Lead Sponsor:
Sanofi
Conditions:
Myocardial Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 sen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00268619
Start Date
June 1 2004
Last Update
January 11 2011
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