FOCUS - Follow up Of Clinical Outcomes: The Long-term AGI-1067 Plus Usual Care Study - FOCUS

AtheroGenics, Inc.0 个研究点目标入组 5,000 人开始时间: 2006年9月29日最近更新: 2012年3月19日

适应症

试验速览

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•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
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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
•- Subjects taking and requiring continued therapy with antiarrhythmic medications
•- A history of intolerance to probucol

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