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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03618108




Registration number
NCT03618108
Ethics application status
Date submitted
1/08/2018
Date registered
7/08/2018
Date last updated
2/08/2021

Titles & IDs
Public title
Anti-chlamydophila Antibiotic Combination Therapy in the Treatment of Patients With Coronary Heart Disease
Scientific title
Phase IIa Prospective Study to Evaluate the Safety and Measure Efficacy of Anti-chlamydophila Antibiotic Combination (ACAC) Therapy Comprising 100mg Doxycycline, 500mg Azithromycin and 300mg Rifabutin in the Treatment of Patients With Coronary Heart Disease (CHD)
Secondary ID [1] 0 0
NC10/C01
Universal Trial Number (UTN)
Trial acronym
ACAC-CHD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 0 0
Chlamydophila Pneumoniae Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Doxycycline Capsule
Treatment: Drugs - Azithromycin Capsule
Treatment: Drugs - Rifabutin Oral Capsule
Treatment: Drugs - Placebo oral capsule
Treatment: Drugs - Placebo Oral Tablet
Treatment: Drugs - Placebo oral capsule

Active comparator: Active - Subjects will be given oral capsules containing the active comparators 50mg oral capsule doxycycline, 250mg oral capsule azithromycin and 150mg oral capsule rifabutin daily (days 1 to 7). From days 8 to 90 subjects will be given 50mg oral capsule doxycycline, 250mg oral capsule azithromycin and 150mg oral capsule rifabutin twice daily.

Placebo comparator: Placebo - subjects will be given sugar capsules identical in form and size to the active comparators, 1 capsule of each bottle (3 separate capsules) daily (days 1 to 7), 1 capsule of each bottle (3 separate capsules) twice daily (days 8 to 90).


Treatment: Drugs: Doxycycline Capsule
doxycycline capsule

Treatment: Drugs: Azithromycin Capsule
azithromycin capsule

Treatment: Drugs: Rifabutin Oral Capsule
rifabutin capsule

Treatment: Drugs: Placebo oral capsule
Placebo oral capsule identical in size and form to doxycycline

Treatment: Drugs: Placebo Oral Tablet
Placebo oral capsule identical in size and form to azithromcyin

Treatment: Drugs: Placebo oral capsule
Placebo oral capsule identical in size and form to rifabutin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate effect of antibiotic therapy through evaluation of fractional flow reserve
Timepoint [1] 0 0
day 90 post initiation of treatment (Visit 3)
Secondary outcome [1] 0 0
Angiographic stenoses changes
Timepoint [1] 0 0
Day 90 post initiation of treatment (Visit 3)
Secondary outcome [2] 0 0
Major adverse Clinical events
Timepoint [2] 0 0
day 90 (visit 3) and Day 180 post initiation of treatment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2020
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Liverpool hospital - Liverpool
Recruitment postcode(s) [1] 0 0
2170 - Liverpool

Funding & Sponsors
Primary sponsor type
Other
Name
Cadrock Pty. Ltd.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Centre for Digestive Diseases, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to see whether the antibiotic combination of 100mg doxycycline, 500mg azithromycin and 300mg rifabutin is a safe and effective treatment for coronary artery disease which has not responded to 'standard treatment'.

Coronary artery disease is the process of plaque build up within the walls of the arteries responsible for supplying the heart with oxygen and nutrients. plaque is usually made up of fatty deposits, minerals and various amounts of tissue and white cells which eventually narrows the artery, reducing blood flow to the heart. The resulting damage and build up of fat leads to inflammation of the arterial wall and eventually the arteries narrow. The researchers involved in this study consider that a pathogen called Chlamydophila pneumoniae, which can live inside cells may cause this inflammation of the arterial wall.

The purpose of this study is to see if treatment with this antibiotic combination in patients with CHD is safe and effective in reducing disease severity measured at coronary angiography and improving quality of life. Approximately 60 patients will be involved in this trial. the treatment period is 90 days with a further 90 day follow up period.
Trial website
https://clinicaltrials.gov/study/NCT03618108
Trial related presentations / publications
Falk E, Shah PK, Fuster V. Coronary plaque disruption. Circulation. 1995 Aug 1;92(3):657-71. doi: 10.1161/01.cir.92.3.657. No abstract available.
Hermus L, Lefrandt JD, Tio RA, Breek JC, Zeebregts CJ. Carotid plaque formation and serum biomarkers. Atherosclerosis. 2010 Nov;213(1):21-9. doi: 10.1016/j.atherosclerosis.2010.05.013. Epub 2010 May 19. Erratum In: Atherosclerosis. 2011 May;216(1):249.
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Borody
Address 0 0
Centre for Digestive Diseases
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03618108