Treating Insulin Resistance in patient after Stroke for prevention of stroke and myocardial infarction after ischemic stroke and transient ischemic attack

INTERVENTION: Trade Name: ACTOS Product Name: Pioglitazone hydrochloride Pharmaceutical Form: Tablet INN or Proposed INN: Pioglitazone hydrochloride CAS Number: 112529‐15‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: ACTOS Product Name: Pioglitazone hydrochloride Product Code: AD‐4833 Pharmaceutical Form: Tablet INN or Proposed INN: pioglitazone hydrochloride CAS Number: 112529‐15‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 45‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Insulin resistance in patients who have had a stroke or transient ischaemic attack Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: To determine if pioglitazone, compared to placebo, will reduce the overall risk for fatal or non‐fatal stroke or fatal or non‐fatal myocardial infarction (MI) among non‐diabetic men and women aged 40 years or older with insulin resistance, who have experienced a recent stroke or transient ischaemic attack (TIA).; ; The sponsor hypothesizes that, among non‐diabetics with insulin resistance, pioglitazone will reduce the rate of occurrence of any main outcome (fatal or non‐fatal stroke or MI) within four years from 27% to 22%. Primary end point(s): Rate of occurrence of fatal or non‐fatal stroke or MI (i.e. % of patients in whom one or more of the events occur) Secondary Objective: To determine if pioglitazone, compared to placebo, will:; 1. Reduce the risk for stroke alone. ; 2. Reduce the risk for acute MI or unstable angina. ; 3. Prevent progression to overt diabetes.; 4. Reduce the risk for all‐cause mortality.; 5. Reduce the risk for cognitive decline.; 6. Reduce the risk for stroke, MI or episodes of CHF (combined). Timepoint(s) of evaluation of this end point: After last patient last visit 2015 SECONDARY OUTCOME: Secondary end point(s): To determine if pioglitazone, compared to placebo, will reduce the risk for stroke and will reduce the risk for acute coronary syndromes ; To determine if pioglitazone, compared to placebo, is effective in preventing progression to overt diabetes. Timepoint(s) of evaluation of this end point: After last patient last visit 2015 INCLUSION CRITERIA: Inclusion Criteria a. Ages 40 years or greater at the time of randomization. b. Ischemic stroke or TIA no less than 14 days and no more than 6 months before randomization c. Documentation of insulin resistance as defined by a value over 3.0 on the Homeostasis Model Assessment of insulin sensitivity (HOMA). d. Both ability and willingness to provide informed consent. e. Presence of none of the exclusion criteria. 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80