Effect of extended-release niacin on myocardial blood flow and flow reserve in patients with coronary artery disease treated with statins - NIFLO
- Conditions
- coronary artery disease and lipid disorder
- Registration Number
- EUCTR2005-004218-34-DE
- Lead Sponsor
- Department of Cardiology, UK Aachen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 46
1.Age >35years.
2.Male or female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device.
3.CAD, angiographically documented
4.HDL-C <45mg%
5.LDL-C <150mg%
6.Current treatment with statin (allowed are: Lovastatin, daily dose =40mg; Simvastatin, daily dose =40mg; Pravastatin, daily dose =40mg; Fluvastatin, daily dose =40mg; Atorvastatin, daily dose =40mg)
7.Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Intolerance to niacin
2.Significant liver disease or liver dysfunction (present or history)
3.Active peptic ulcer disease within 3 months
4.Arterial bleeding
5.Known Ethanol abuse
6.Abnormal liver enzymes (>3x upper normal reference value)
7.Hereditary muscle disease
8.History of myopathy or myositis under HMG-CoA-Reductase-Inhibitor or fibrate
9.Abnormal serum creatine-kinase (>3x upper normal reference value)
10.Concomitant use of medication with a high probability of increasing the risk for hepatotoxicity or myopathy, such as those predominantly metabolized by cytochrome P450 system 3A4, including fibrates, cyclosporine, amiodarone, verapamil, diltiazem, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycine, human immunodeficiency virus protease inhibitors, nefazodone, danazol; lipid-lowering drugs such as bile-acid sequestrants, cholesterol absorption inhibitors (e.g., ezetimibe); high-dose, antioxidant vitamins (vitamins C, E, or beta carotene) that can interfere with the HDL-raising effect of niacin.
11.Renal insufficiency with serum creatinine >2,0mg%
12.Untreated hypothyroidism
13.Uncontrolled diabetes mellitus with fasting glucose >180mg% or hemoglobin A1c >9%.
14.Thrombocytopenia < 100Giga/l
15.Arterial hypotension (systolic blood pressure <90mmHg)
16.Myocardial infarction, PTCA or CABG within 3months
17.Need for coronary revascularization within next 6 months
18.Chronic obstructive pulmonary disease requiring medication
19.High-grade AV-block
20.Pregnant or nursing women
21.Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk form 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
22.Participation in other clinical trial 30days before randomization
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Hypothesis to be tested: Extended-release niacin increases myocardial blood flow reserve in patients with coronary artery disease (CAD) treated with statins;Secondary Objective: ;Primary end point(s): Myocardial blood flow and flow reserve assessed by 13N-Ammonia-PET (rest/dipyridamol) before and after 6 month therapy
- Secondary Outcome Measures
Name Time Method