EUCTR2006-002657-71-GB
Active, not recruiting
Not Applicable
FOCUS - Follow up Of Clinical Outcomes: The Long-term AGI-1067 Plus Usual Care Study - FOCUS
Conditionscoronary artery disease
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- AtheroGenics, Inc.
- Enrollment
- 5,000
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Male or female subjects who have completed the ARISE trial are eligible to participate in FOCUS.
- •Main inclusion criteria ARISE trial:
- •\- Subjects with a recent diagnosis of coronary artery disease as evidenced by an admission with a diagnosis of Acute MI or unstable angina not less than 14 days and not more than one year prior to randomization
- •\- Male or female subjects in one of the two following groups:
- •a) Subjects with diabetes mellitus (NIDDM or IDDM) 18 years of age or older
- •b) Subjects (without diabetes mellitus) 55 years of age or older with one of the following additional risk factors:(1\) Age 60 or older (2\) Low HDL\-C (3\) Previous Myocardial Infarction, or diagnosis of Atherosclerosis in a non\-coronary vessel (4\) Prior history of CHF (Congestive Heart Failure) or ejection fraction \< 40%
- •\- Females must be non\-lactating and not of child bearing potential (post\-menopausal or surgically sterilized) or must use a reliable method of birth control considered suitable by the Investigator.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •Male or female subjects who have completed the ARISE trial are eligible to participate in FOCUS.
- •Main exclusion criteria ARISE trial:
- •\- Subjects who are hemodynamically or clinically unstable
- •\- Subjects who have had a PCI in the last 30 days
- •\- Subjects who have had coronary artery bypass (CAB) or coronary artery bypass graft (CABG) surgery in the last 3 months
- •\- Subjects on a waiting list for revascularization or revascularization already planned
- •\- Current symptoms consistent with moderate or severe CHF despite medical therapy
- •\- In the opinion of the Principal Investigator (or designee), clinically significant valvular heart disease or Hypertrophic Obstructive Cardiomyopathy
- •\- Uncontrolled hypertension
- •\- Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the Investigator
Investigators
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