RESTORE-IT-Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients With a History of Atherosclerotic Disease

Exclusion Criteria

• •The patient lacks evidence of intermediate or advanced carotid atherosclerotic lesions or has heavily calcified plaque or poor image quality of their carotid arteries as determined by the MRI lab.
• •Patient has critical limb ischemia as evidenced by ischemic rest pain, ulceration, or gangrene.
• •Patient has new, previously unrecognized clinically significant electrocardiogram (ECG) abnormalities.
• •Patient has liver function tests \> 3.0 times the upper limit of normal, serum creatinine \> 1.8 mg/dL for females and \>2.0 mg/dL for males and a eGFR value \<30 mL/min/1.73 m2. Enrollment of patients with eGFR values of between 30 and 59 mL/min/1.73 m2 will be left to the discretion of the investigator. Patients with abnormal laboratory values which are deemed clinically significant by the investigator will not be enrolled.
• •Patient has had a recent (\< 6 months) coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), carotid endarterectomy (CEA), carotid artery stent, or lower extremity revascularization/amputation.
• •Patient plans for surgical/endovascular intervention for carotid and/or coronary during the course of the study.
• •Patient has or being evaluated or treated for tuberculosis. Patients who were treated previously for tuberculosis but presently have inactive disease may be included.
• •Patient has a chest x-ray obtained within the last month that is consistent with possible tuberculosis.
• •Patient has a history of malignant neoplasm within the previous 5 years (except curable non-melanoma skin malignancies).
• •Patient has a known immunodeficient state or is being treated with immunosuppressive drugs including high-dose steroids or cyclosporine.
• •Patient has an active infection requiring systemic or oral antibiotics. Patients with prior infection must have discontinued such treatments at least 14 days prior to administration of investigational agent.
• •Patient has an uncontrolled, unstable or recently diagnosed autoimmune disease, including but not limited to systemic lupus, inflammatory bowel disease, sarcoidosis, rheumatoid arthritis, or psoriasis.
• •Patient has a recent history of alcohol abuse, illicit drug use or drug abuse or significant mental illness.
• •Patient has a known or suspected allergy to the study medication(s) or class of study medication (rifamycins).
• •Patient chronically uses antibacterials or has previously received rifalazil.
• •Patient has a known or suspected allergy to MRI contrast agents (e.g., gadolinium) and/or has any medical or physical condition that would prevent them from receiving a gadolinium-based contrast agent or an MRI examination.
• •Patient has participated in any clinical trial of an investigational drug, device, or medical procedure within 30 days prior to Baseline of the study.
• •Patient is enrolled or plans to enroll in another clinical drug or device/interventional trial during this study.