Inhibiting the progression of atherosclerosis in patients with carotid arteries stenosis and dyslipidemia. MedDRA version: 17.1 Level: PT Classification code 10007687 Term: Carotid artery stenosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.1 Level: LLT Classification code 10058110 Term: Dyslipidemia System Organ Class: 100000004861
Conditions
Interventions
Product Name: Nicotinic acid, 500 mg, prolonged-release tablet
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: NICOTINIC ACID
CAS Number: 59-67-6
Other descriptive name: NICOTINIC A
Sponsors
SciencePharma spólka z ograniczona odpowiedzialnoscia sp. j.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Caucasian men and women aged = 18 years; 2. Stenosis of at least one internal carotid artery (ICA) 100 mg / dL (> 2.5 mmol / L) despite taking simvastatin 20 mg daily or equivalent dose of another statin for at least last 28 days; 4. LDL-C level > 115 mg / dl (> 3 mmol / L) in patients not taking any statin over the last 28 days; 5. Patients capable of understanding and following the study procedures; 6. Signing of Informed Consent Form to participate the study before the qualification procedures begin. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. Known allergy and/or hypersensitivity to nicotinic acid and/or its derivatives and/or to any study product excipients; 2. Known allergy and/or hypersensitivity to simvastatin and/or its derivatives and/or to any study product excipients; 3. Pregnancy or lactation period in females; 4. Stenosis of at least one internal carotid artery (ICA) = 70% assessed by carotid arteries ultrasound; 5. Symptomatic stenosis of any carotid artery, regardless of the stenosis degree; 6. Patients scheduled to undergo invasive treatment of any carotid artery: carotid endarterectomy (CEA) or cartoid artery stenting (CAS); 7. History of previous CEA or CAS of any carotid artery; 8. Hypotension (systolic blood pressure 180 mmHg or diastolic blood pressure > 110 mmHg at screening and/or at any time within 3 months prior to enrolment; 10. Unstable angina pectoris; 11. Heart failure (NYHA III-IV); 12. Symptomatic stenosis or symptomatic aortic regurgitation; 13. Renal failure - estimated creatinine clearance 3 times the upper limit of normal range; 16. Jaudince; 17. Ascites found in physical examination; 18. Active peptic ulcer disease; 19. Gout or uric acid levels above the upper limit of normal range; 20. Primary, hereditaryl, monogenic, homo- or heterozygotic familiar dyslipidemia 21. Triglycerides level > 400 mg/dl (> 4.6 mmol/l); 22. Individual or familiar anamnesis of hereditary muscular system disorders; 23. History of statins- or fibrates-induced muscle toxicity; 24. Inflammatory muscle diseases; 25. Clinical symptoms of myopathy; 26. CK activity exceeds 5 times the upper limit of the normal range; 27. Type 1 diabetes or diabetes mellitus with a known etiology (secondary); 28. The percentage of glycated hemoglobin = 12.0; 29. Free thyroxine (FT4) concentration below the lower limit of normal range; 30. Glaucoma; 31. History of malignant neoplastic disease that has not been in remission for at least 5 years at screening; 32. Taking fibrates, ion exchange resins, or ezetimibe within 90 days prior to enrollment; 33. Systemic administration of following drugs, if it is not possible to stop taking those drugs during study; • antifungal drugs: fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole; • antibacterial drugs: erythromycin, clarithromycin, telithromycin, fusidic acid; • antiviral drugs: HIV protease inhibitors (eg. Nelflinawir), kobicystatu, boceprevir, telaprevir; • medicines used in cardiovascular system diseases: amiodarone, dronedarone, verapamil, ranolazine; • nefazodone, cyclosporine, danazol, lomitapide; • vitamin K antagonists (eg. Acenocoumarol, warfarin, phenprocoumon); • non-investigational medicinal product containing nicotinic acid, nicotinic acid or nicotinamide preparations (vitamin. B3 vitamin. PP) or other nicotinic acid derivatives (eg. hydroxymethylamide of nicotinic acid, inositol hexanicotinate); • preparations containing polyunsaturated fatty acids, ?-3. 34. Participation in any clinical trial within 90 days prior to enrollment; 35. Severe subjects who are known or suspect
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of nicotinic acid used in combination with simvastatin at a dose of 20 mg daily in comparison to simvastatin administered at a dose of 40 mg daily in inhibiting the progression of atherosclerotic lesions after 6 months of therapy in patients with carotid artery stenosis and dyslipidemia.;Secondary Objective: 1. To evaluate the influence of nicotinic acid used in combination with simvastatin at a dose of 20 mg daily on serum lipid fractions concentrations in comparison to simvastatin administered at a dose of 40 mg daily. 2. To evaluate the influence of nicotinic acid used in combination with simvastatin at a dose of 20 mg daily on frequency of major cardiovascular events in comparison to simvastatin administered at a dose of 40 mg daily. ;Primary end point(s): Change in common carotid arteries intima-media thickness, assessed by ultrasound, after 6 months of the therapy.;Timepoint(s) of evaluation of this end point: 1. When subject abandonment of treatment. 2. On the last medical examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Groups will be compared for: 1. Change in LDL cholesterol level (LDL-C); 2. Change in HDL cholesterol level (HDL-C); 3. Change in non-HDL cholesterol level (non-HDL-C); 4. Change in total cholesterol (TC); 5. Change in triglycerides level (TG); 6. Major cardiovascular events (composite endpoint): • brain stroke (ischemic, hemorrhagic, indefinite); • transient (cerebral) ischemic attack (TIA); • myocardial infarction; • brain stroke mortality; • myocardial infarction mortality; • sudden cardiac death ;Timepoint(s) of evaluation of this end point: 1. When the study will be finished. 2. When subject abandonment of treatment. 3. On the last medical examination. | — |
Countries
Poland
Contacts
Public ContactCoordinating Investigator
Prof. nadzw. dr hab. n. med. Piotr Szopinski
Outcome results
None listed