Anti-chlamydophila antibiotic combination therapy in the treatment of patients with Coronary Heart Disease

Phase 2

Recruiting

• Conditions: Coronary Heart Disease; Chlamydophila pneumoniae infection; Cardiovascular - Coronary heart disease; Infection - Other infectious diseases

• Registration Number: ACTRN12618000260224
• Lead Sponsor: Centre for Digestive Diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-19
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of antibiotic combination therapy on objective measures of improvement in coronary flow as determined by fractional flow reserve (FFR) in subjects undergoing percutaneous coronary intervention (PCI) with non-critical lesions in non-culprit arteries.[Day 90 post initiation of treatment (Visit 3)]

Secondary Outcome Measures

Name	Time	Method
To evaluate angiographic stenoses changes (QCA) via diagnostic angiography during the ACAC trial.[Day 90 post initiation of treatment (Visit 3)];To record major adverse clinical events (MACE), including death, recurrent myocardial infarction, stroke and major bleeding via investigator adverse event reporting[Day 90 (Visit 3) & Day 180 post initiation of treatment]