Effect of Atorvastatin on Subclinical Atherosclerosis
- Registration Number
- NCT04101136
- Lead Sponsor
- Dr Cipto Mangunkusumo General Hospital
- Brief Summary
Statin administration is supposed to reduce subclinical atherosclerosis by decreasing LDL cholesterol levels, possibly via lipid-independent anti-inflammatory effect. Its pleiotropic properties also adding beneficial effect against CMV infection.
The investigators plan to study atorvastatin in virally- suppressed HIV-infected patients on stable ART with CMV seropositive and statin-naïve to evaluate the subclinical atherosclerosis changes assessed by carotid intima media thickness (CIMT).
- Detailed Description
Extended description of the protocol, including more technical information
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- Ages between 20 to 45 years old
- Using stable ART at least 1 year
- Positive IgG CMV
- Viral load HIV RNA <50 copies / ml
- Undergoing hepatitis C DAA therapy
- Decompensated cirrhosis or acute liver failure
- History of coronary artery disease
- Diabetes mellitus
- History of of brain infection, epilepsy, stroke
- History of rhabdomyolysis or myopathy
- Pregnant or breastfeeding
- Severe depression
- Using statin therapy in the past 6 weeks
- History of statin hypersensitivity
- Framingham Risk Score above 10% within LDL ≥130
- Framingham Risk Score under 10% within LDL ≥160
- Out of Periodontitis Index (Upper right molars, top series, upper left molars, lower right molars, bottom series, lower left molars)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 20 mg Atorvastatin - placebo controlled clinical trial The placebo tablets will be prepared by Cipto Mangunkusumo hospital pharmacist, were composed of starch and were similar to atorvastatin tablets in size, shape, and colour. Atorvastatin 20 mg Atorvastatin - placebo controlled clinical trial Study pharmacist will make code (A and B) for atorvastatin and placebo, then save the code in safe place. Pharmacist will record each subject as participant received A or B intervention.
- Primary Outcome Measures
Name Time Method Carotid intima medial tunica change (1) 0-week visit, (2) 48-week visit Numerical changes (in millimeter) between baseline and 48 weeks. Common Carotid Artery (CCA) intima media thickness measured by using B mode imaging system (Affiniti 70 series), equipped with a linear array transducer \> 7 MHz with minimal compression (\<10:1) and footprint of at least 3 cm. This procedure is operated by certified Cardiologist.
Reference Siomva I. Intima-media thickness: appropriate evaluation and proper measurement, described. ESC. May 2015;15:21.
- Secondary Outcome Measures
Name Time Method Flow mediated vasodilatation change (1) 0-week visit, (2) 48-week visit Numerical changes (in percentage) between baseline and 48 weeks FMD.
Using a high-resolution ultrasound linear array transducer, longitudinal images of the right brachial artery (mostly 3-15 cm above the elbow) were recorded at the baseline and for 3 minutes after cuff deflation following suprasystolic compression (50 mmHg over the systolic blood pressure) of the right forearm for 5 minutes. This procedure is operated by certified cardiologist.
Reference:
Charakida M, Masi S, Luscher TF, Kastelein JJ, Deanfield JE.Assessment of atherosclerosis: the role of flow-mediated dilatation.Eur Heart J. 2010 Dec;31(23):2854-61Liver steatosis change (1) 0-week visit, (2) 48-week visit Numerical changes (in dB/m) between baseline and 48 weeks. The measurement of steatosis using the Fibroscan (Echosens) equipped with CAP software. dB/m. This procedure is operated by certified hepatologist.
Fasting lipid change (1) 0-week visit, (2) 48-week visit Numerical changes of fasting lipid profile consist of total cholesterol, LDL-C, HDL-C and triglyceride in mg/dL. Range of fasting is 8 - 10 hours. The test is located in Cipto Mangunkusumo Hospital or Prodia Laboratory Clinic.
Soluble CD14 change (1) 0-week visit, (2) 48-week visit The numerical change of sCD14 (in pg/mL) between 0-week visit and 48-week visit. This examination located in Indonesian Medical Education and Research Institute (IMERI) laboratory
Neurocognitive function change (1) 0-week visit, (2) 24-week visit, (3) 48-week visit Mean or median changes of neurocognitive function change. Neurologist will do supervision while subject do the test. The measurement tool is questionnaire named "neurocognitive test". This item will comprising several aspects:
1. Trail making test
2. Symbol digit modalities test
3. Brief visuospatial memory test revised
4. California verbal learning test IICommunity Periodontal Index (CPI) (1) 0-week visit, (2) 48-week visit This Community Periodontal Index takes into consideration 10 teeth in the oral cavity i.e. 17, 16, 11, 26, 27, 37, 36, 31, 46 and 47 and subsequently evaluates the occurrence of gingival bleeding, presence of supra- and subgingival calculus, periodontal pockets with probing depths between 3.5-6.0 mm, as well as clinical attachment loss. This procedure done by dentist.
CPI score:
* Score 0: health periodontal conditions
* Score 1: gingival bleeding on probing
* Score 2: calculus and bleeding
* Score 3: periodontal pocket 4-5 mm
* Score 4: periodontal pocket ≥6 mm Only the worst finding from the index teeth is recorded per sextant of teeth.beta 2-microglobulin change (1) 0-week visit, (2) 48-week visit The numerical change of beta 2-microglobulin (in pg/mL) between 0-week visit and 48-week visit. This examination located in Indonesian Medical Education and Research Institute (IMERI) laboratory
High Sensitivity C-Reactive Protein (hsCRP) change (1) 0-week visit, (2) 48-week visit The numerical change of hsCRP (in mg/L) between 0-week visit and 48-week visit. This examination located in Indonesian Medical Education and Research Institute (IMERI) laboratory
Liver fibrosis change (1) 0-week visit, (2) 48-week visit Numerical changes (in KPa) between baseline and 48 week. The measurement of liver stiffness which uses the velocity of shear waves that travel through the liver using the Fibroscan (Echosens) device. This procedure is operated by certified hepatologist.
ICAM-1 change (1) 0-week visit, (2) 48-week visit The numerical change of ICAM-1 (in pg/mL) between 0-week visit and 48-week visit. This examination located in Indonesian Medical Education and Research Institute (IMERI) laboratory
Vascular Cell Adhesion Molecule-1 (V CAM-1) change (1) 0-week visit, (2) 48-week visit The numerical change of V CAM-1 (in pg/mL) between 0-week visit and 48-week visit. This examination located in Indonesian Medical Education and Research Institute (IMERI) laboratory
Trial Locations
- Locations (1)
Cipto Mangunkusumo General Hospital
🇮🇩Jakarta, Center Jakarta, Indonesia