coronary artery disease
Conditions
Interventions
Product Name: AGI-1067
Pharmaceutical Form: Film-coated tablet
CAS Number: 216167-82-7
Current Sponsor code: AGI-1067
Other descriptive name: succinobucol
Concentration unit: mg milligram(s)
Concentra
Sponsors
AtheroGenics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 - Subjects taking and requiring continued therapy with antiarrhythmic medications - A history of intolerance to probucol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of FOCUS is to evaluate clinical safety outcomes (cardiovascular and noncardiovascular) in subjects receiving long-term (> 36 months) AGI-1067 treatment. ;Secondary Objective: ;Primary end point(s): 10 major adverse cardiovascular events: 1. All death to determine cardiovascular death 2. Non-fatal myocardial infarction 3. Resuscitated cardiac arrest 4. Use of coronary revascularization 5. Hospitalization for angina pectoris 6. Hospitalization for CHF 7. Fatal, non-fatal stroke and Transient ischemic attack (TIA) 8. New onset Diabetes Mellitus (NODM) 9. Any admission for a procedure for the treatment of PVD 10. Incidence of End Stage Renal Disease (ESRD) | — |
Countries
United Kingdom
Outcome results
None listed