Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00385385
Other study ID # ABI-1648-026
Secondary ID
Status Recruiting
Phase Phase 2
First received October 6, 2006
Last updated April 27, 2007
Start date October 2006
Est. completion date September 2008

Study information

Verified date April 2007
Source ActivBiotics
Contact Emelia Klonowski Klonowski
Phone 914-289-1581
Email eklonowski@activbiotics.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate an antibiotic therapy called Rifalazil to determine its effect on hardening of the carotid arteries.


Description:

To evaluate the effect of treatment with rifalazil versus placebo taken once weekly for 12 weeks on carotid atherosclerotic disease progression in patients who test positive for Chlamydia pneumoniae. Measurements of the carotid artery wall (intima-media thickness) and plaque characteristics will be evaluated with high-resolution magnetic resonance imaging (MRI) and carotid ultrasound. at Baseline and at 6,12 and 18 months following initiation of drug treatment in Chlamydia pneumoniae seropositive patients with a history of atherosclerotic disease. Biomarkers will be collected throughout the study. Safety will be evaluated by the collection and analysis of laboratory parameters, vital signs, electrocardiograms, physical examination and adverse events. Seventy two patients will be enrolled in this study. There will be a total of approximately 7-9 visits which will occur over an 18 month period.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date September 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria:

- Male or female patients between 50 and 85 years of age.

- Patient has seropositive evidence of C. pneumoniae defined by IgG antibody titers = 1:128 on microimmunofluorescence assay.

- The patient meets at least one of the following criteria:

1. Diagnosis of PAD: i. Ankle-brachial index (ABI) of <0.90 at rest in either leg, or toe brachial index of < 0.7 if ankle pressure is calcified. ii. Known PAD on the basis of history or symptoms of intermittent claudication, prior endovascular or surgical revascularization.

2. Known large vessel (non-cardioembolic) cerebrovascular event (stroke or TIA) within the last three years or carotid stenosis of >40% and = 80% by Doppler ultrasound or asymptomatic carotid artery disease defined by a total plaque area >100 mm2and carotid stenosis of = 80%by Doppler ultrasound.

3. Known coronary artery disease on the basis of an exercise tolerance test positive for myocardial ischemia, or history of a prior myocardial infarction (greater than 6 months), or prior percutaneous coronary intervention and/or surgical revascularization (greater that 6 months).

- Patient has a maximal IMT measurement by ultrasound in either the left or right common carotid artery of = 0.70 mm and at least one or more echogenic carotid plaques detectable in either the right or left side of the carotid artery.

- Patient is able to undergo magnetic resonance (MR) examination and MR baseline images obtained are of suitable image quality for analysis.

- If patient is taking cilostazol, pentoxifylline, or other approved drugs for the treatment of PAD and/or intermittent claudication or taking a statin, patient has to be on the medication for at least 6 months prior to Screening.

- Patients who have recently discontinued medications for PAD and/or intermittent claudication or statin must “wash-out” for at least one month prior to screening.

- Male and female patients must agree to use an effective form of birth control throughout the study period.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind


Intervention

Drug:
Rifalazil


Locations

Country Name City State
Canada Robarts Research Institute London Ontario
United States Baylor College of Medicine Houston Texas
United States Thoracic & Cardiovascular Healthcare Foundation Lansing Michigan
United States St. Francis Hospital Roslyn New York
United States Swedish Medical Center Seattle Washington
United States Stony Brook University Medical Center Stony Brook New York

Sponsors (1)

Lead Sponsor Collaborator
ActivBiotics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the treatment with Rifalazil versus placebo on high-resolution magnetic resonance imaging (MRI) determined by the normalized wall index (NWI) over a segment of the carotid artery at Day 180.
Primary NWI is defined as the wall area (WA) over the length of the arterial segment studied divided by the sum of the wall area plus the lumen area (LA) over the length of the arterial segment studied [NWI = WA / (WA + LA)].
Secondary To evaluate the effect of rifalazil versus placebo on carotid intima media thickness (IMT), and carotid plaque composition by ultrasound and MRI and to determine the overall safety of a 12 week regimen of rifalazil administered once weekly.
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A