Prospective Study to evaluate the safety and measure efficacy of anti-Chlamydophila antibiotic combination (ACAC) therapy in the treatment of patients with Coronary Heart Disease (CHD)

Centre for Digestive Diseases0 个研究点目标入组 60 人开始时间: 2018年2月19日最近更新: 2018年12月10日

适应症

试验速览

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•1. Males and females (without childbearing potential as evidenced by hysterectomy, tubal ligation or at least one year post-menopause) aged 18 to 80 years, inclusive.
•2. Ability to provide written informed consent to participate in the study.
•3. Subjects with documented recent acute coronary syndrome (ACS) or evidence of myocardial ischemia.
•4. Subjects who have a culprit lesion suitable for PCI, and a non-critical lesion in another vessel suitable for staged PCI with an FFR of <0.80, for subjects undergoing diagnostic angiography and FFR without ad hoc PCI.
•5. No serious co-morbidities, which might interfere with the subject’s ability to enter the study.
•6. Able to communicate effectively with the study team and to comply with the protocol.

•1. Females that are of child bearing potential
•2. Subjects without a non-culprit lesion considered appropriate to plan a staged PCI.
•3. Clinically significant haematologic, hepatic, metabolic, renal, rheumatologic, anaphylactic reactions, neurological or psychiatric disease
•4. Clinical evidence of any other disease, which might interfere with the subject’s ability to enter the trial.
•5. Concomitant administration of medications that may interfere with treatment as assessed by the Investigator, including allergy to any component of the therapy.
•6. Concomitant administration of any medication prohibited for use during this study (e.g. colchicine)
•7. Male subjects consuming greater than 60g alcohol per day, or female subjects consuming greater than 40g alcohol per day.
•8. Evidence of any recent history of, or current recreational drug abuse
•9. Serious adverse reaction or hypersensitivity to therapeutic drugs.
•10. Unable and to comply with the study requirements.
•11. Subjects who have been involved in an experimental drug protocol within the past four weeks.
•If a subject becomes pregnant during the course of the study, they will be immediately withdrawn and treated in the way least likely to harm both subject and foetus.

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