ot applicable

Phase 1

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

• Registration Number: EUCTR2010-023801-36-BE
• Lead Sponsor: Resverlogix Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-26
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 310

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.
- This vessel need not be the target coronary artery for IVUS.
- Any vessel with previous PCI may not be used as the target coronary artery.
B. Left Main Coronary Artery:
- Must not have a > 50% reduction in lumen diameter by visual angiographic estimation.
C. Target Coronary Artery for IVUS
- Must be accessible to the IVUS catheter.
- Must have a <50% reduction in lumen diameter by angiographic visual estimation throughout a segment of at least 40 mm in length (the target segment”). A lesion of up to 60% stenosis is permitted, distal to the target segment. A single branch of the target vessel” may have a narrowing up to but <70% by visual estimation, as long as the target segment contains no lesion >50%, provided that the branch in question is not a target for PCI or CABG.
- Has not undergone prior percutaneous coronary intervention or coronary artery bypass graft surgery.
- The target vessel is not currently a candidate for intervention or a likely candidate for intervention over the next 6 months.
- The target vessel may not be a bypass graft.
- The target vessel may not be a bypassed vessel.
- The target vessel may not be the culprit vessel for a previous MI.
7. Have given signed informed consent to participate in this study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 310
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 310

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.
11. Atorvastatin >40 mg daily at Visit 1
12. Rosuvastatin>20 mg daily at Visit 1
13. Triglycerides >400 mg/dL at Visit 1.
14. Any medical or surgical condition which might significantly alter the absorption, distribution, metabolism or excretion of medication including, but not limited to any of the following: cholecystitis, Crohn’s disease, ulcerative colitis, or any gastric bypass alteration.
15. Evidence of hepatic disease as determined by any one of the following:
- ALT, AST, GGT that is >ULN by central lab at Visit 1
- a history of hepatic encephalopathy
- history of Hepatitis B, C or E
- history of esophageal varices
- history of porta-caval shunt.
Any one of the following liver enzymes that is >ULN by central lab at Visit 1
. ALT
. AST
.GGT
16. A total bilirubin that is >ULN by central lab at Visit 1
17. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
18. History or evidence of drug or alcohol abuse within the last 12 months.
19. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
20. Use of other investigational drugs and devices at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
21.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified