ARISE - Aggressive Reduction of Inflammation Stops Events

• Status: Unknown status
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the safety and efficacy of AGI-1067, as compared to placebo, in the treatment of vascular inflammation and atherosclerosis by assessing the reduction in cardiovascular events.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AtheroGenics

Criteria

IRB-approved informed written consent must be provided by all subjects prior to screening and study entry.

A. Inclusion Criteria

1. Informed written consent from the subject prior to Screening

2. Acute MI or unstable angina not less than 14 days and not more than one year prior to randomization

3. Male or female subjects in one of the two following groups:

1. Subjects with diabetes mellitus (NIDDM or IDDM) 18 years of age or older

2. Subjects (without diabetes mellitus) 55 years of age or older with one of the following additional risk factors:

(i) Age 60 or older (ii) Low HDL-C as evidenced by: Male: HDL-C < 40 mg/dL or Female:

HDL-C < 50 mg/dL (iii) Previous Myocardial Infarction (in addition to the index event), or diagnosis of Atherosclerosis in a non-coronary vessel (e.g. history of prior stroke, presence of PVD) (iv) Prior history of CHF (Congestive Heart Failure) or ejection fraction < 40%

4. Females must be non-lactating and not of child bearing potential

B. Exclusion Criteria

1. Subjects who are hemodynamically or clinically unstable

2. Subjects who have had a PCI in the last 30 days

3. Subjects who have had coronary artery bypass (CABG) in the last 3 months

4. Subjects on a waiting list for revascularization or revascularization already planned

5. Current symptoms consistent with moderate or severe CHF despite medical therapy

6. Clinically significant valvular heart disease or Hypertrophic Obstructive Cardiomyopathy

7. Uncontrolled hypertension (e.g., sitting systolic BP > 180 mm Hg on antihypertensive therapy)

8. Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction

9. Subjects taking and requiring continued therapy with drugs known to significantly prolong the QT interval (this will not include drugs associated with minor effect on the QT interval of less than 15 msec.)

10. Life-threatening illness where the subject is not expected to survive for 2 years or any history of cancer or malignancy within the past 5 years except for basal cell carcinoma or squamous cell carcinoma of the skin

11. A history of intolerance to probucol (Lorelco™)

12. Unreliability as a study participant based on the Investigator's (or designee's) knowledge of the subject (e.g., alcohol or other drug abuse, inability or unwillingness to adhere to the protocol, or psychosis)

13. Participation in any investigational drug study within 30 days prior to study entry, or expectation to participate in any other investigational drug study during the course of the ARISE study.

14. Previous participation in a study involving AGI-1067