FOCUS:Focus On Coronary Unstable Syndromes

Sanofi

Status and phase

Completed

Phase 3

Conditions

Myocardial Ischemia

Treatments

Drug: Ramipril

Study type

Interventional

Funder types

Industry

Identifiers

NCT00268619

HOE498_3501

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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