1. Patients diagnosed as having a stroke based on the WHO Criteria Patients with transient ischaemic attacks will be included if symptoms of motor or sensory loss were demonstrable with full recovery within 24 hours. Only strokes and TIA that are ischaemic in nature (thrombo-embolic) will be included in the study
Conditions
Interventions
Trade Name: Niaspan
Product Name: Niaspan
Pharmaceutical Form: Prolonged-release tablet
Pharmaceutical form of the placebo: Prolonged-release tablet
Sponsors
Sandwell Medical Research Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects demonstrating their willingness to participate in the study and comply with its procedures by signing a written informed consent. 2. Subjects must be more than 18 yrs of age. 3. Subjects must have an LDL cholesterol level =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects whose liver transaminases (ALT, AST) are 1 ½ times the upper limit of normal or active liver disease at visit 1. 1. Subjects with evidence of current myopathy (including subjects with CK > 1 ½ times above the upper limit of normal at visit 3 (baseline). 2. Subjects with clinical laboratory tests (blood chemistries and urine analysis) outside the normal range that are clinically unacceptable to study physicians (EAH, KS, HSL, GYHL) during visits 1-3. 3. Subjects that are type 2 diabetic that have had a change in anti-diabetic therapy within 3 months of visit 1. 4. Subjects who have known hypersensitivity to either Simvastatin or Niaspan. 5. Any condition or situation, which, in the opinion of the lead study investigator (EAH), might pose a risk to the subject or interfere with the participation in the study (including hypothyroidism, severe cardiovascular disease (events within 3 months of visit 1)). 6. Female subjects who are pregnant, breast feeding or of childbearing potential, who are not using a suitable method of birth control. 7. Subjects who have not observed the designated washout periods for any of the prohibited medications outlined in section 6.1. 8. Uncontrolled hypertension (treated or untreated) at visit 3: systolic blood pressure >160mmHg or diastolic blood pressure >100mgHg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): • To compare the efficacy of co-administration of Niaspan (1000-2000mg) with Simvastatin (10-40mg) versus placebo with Simvastatin (10-40mg) in carotid artery IMT regression after 12 and 24 months.;Main Objective: Compare the safety and efficacy of the co-admistration of niaspan with statndard lipid lowering therapy (simvastatin) vs. simvastatin with placebo amongst South Asian stroke survivors (280 in total). Efficacy is determined by changes in carotid intima thickness at 12 and 24 months following randomisation. ; Secondary Objective: Determine the effects of co-admistration of niaspan with statndard lipid lowering therapy (simvastatin) vs. simvastatin with placebo on 1. Quality of life measures 2. inflammatory markers of atherosclerosis 3. dyslpidaemia associated with stroke | — |
Countries
United Kingdom
Outcome results
None listed