Phase IIb multi-center, double-blind, randomized, parallel group, placebo-controlled clinical trial for the assessment of coronary plaque changes with RVX000222, as determined by intravascular ultrasound - ApoA-I Synthesis Stimulation and Intravascular Ultrasound for Coronary Atheroma Regression Eval.

Resverlogix Corp.0 sites310 target enrollmentSeptember 26, 2012

ConditionsCoronary Artery Disease MedDRA version: 15.0Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Resverlogix Corp.
Enrollment: 310
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 26, 2012

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Resverlogix Corp.

Eligibility Criteria

Inclusion Criteria

•1\. Male and female patient’s \=18 years of age who are scheduled to undergo coronary angiography for a clinical indication.
•2\. Women of child\-bearing potential, that is, women not surgically sterilized and between menarche and 1 year post menopause, must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a reliable method of birth control (for example, use of oral contraceptives or Norplant®; a reliable barrier method of birth control (diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) during the study and for one month following the last dose of study drug.
•3\. Current (Local lab within 60 days prior to Visit 1\)
•HDL\-C of \=45 mg/dL (1\.2 mmol/L) for females
•HDL\-C of \=40 mg/dL (1\.0 mmol/L) for males.
•4\. In the opinion of the investigator patients currently not on statin therapy will be able to start either atorvastatin (10 mg, 20mg or 40mg) or rosuvastatin (5mg, 10mg or 20 mg) at Visit 1\.
•5\. In the opinion of the investigator patients currently on statin therapy other than atorvastatin (10 mg, 20mg or 40mg) or rosuvastatin (5mg, 10mg or 20 mg) can be switched to rosuvastatin (5mg, 10mg or 20 mg) at Visit 1\.
•6\. Patients must meet all of the following criteria at the qualifying coronary catheterization procedure:
•A. Entire Coronary Circulation:
•\- Angiographic evidence of coronary heart disease as defined by at least one lesion in any of the three major native coronary arteries that has \>20% reduction in lumen diameter by angiographic visual estimation or prior history of PCI.

Exclusion Criteria

•1\. Clinically significant heart disease which will require coronary bypass, PCI, cardiac transplantation, surgical repair and/or replacement during the course of the study.
•2\. Any elective surgical procedure that would require general anesthesia during the course of the study
•3\. Coronary artery bypass graft (CABG) procedure within the past 90 days.
•4\. Previous or current diagnosis of severe heart failure (NYHA Class III\-IV) or a documented left ventricular ejection fraction (LVEF) of \<25% as determined by contrast left ventriculography, radionuclide ventriculography or echocardiography the absence of an LVEF measurement in a patient without a previous or current diagnosis of heart failure does not prohibit entry into the study.
•5\. Patients with evidence of cardiac electrophysiologic instability including a history of uncontrolled ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response heart rate of \> 100 beats per minute at rest within 4 weeks prior to Visit 1\.
•6\. Evidence of renal impairment as determined by any one of the following: serum creatinine \>1\.5 mg/dL (\>133 mcmol/L) by central lab at Visit 1, a calculated creatinine clearance less than 60 ml/min at Visit 1, a history of dialysis, or a history of nephrotic syndrome.
•7\. Have hypertension that is uncontrolled defined as 2 consecutive measurements of sitting blood pressure of systolic \>160 mm Hg or diastolic \>95 mm Hg at Visit 1\.
•8\. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive ß\-hCG laboratory test (\=5 mIU/mL).
•9\. Current or recent (within 12 month prior to Visit 1\) treatment with immunosuppressants (eg, Cyclosporine).
•10\. Use of fibrates any dose or niacin/nicotinic acid 250 mg or more within 90 days prior to Visit 1\.