Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-30 @ 11:24 AM
Study NCT ID:
NCT00771004
Status:
COMPLETED
Last Update Posted:
2010-07-05
First Post:
2008-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Pioglitazone on Myocardial Function in Patients Undergoing Coronary Stent Implantation.
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
Pilot Trial Studying the Effects of Pioglitazone in Comparison to Placebo on Myocardial Function and Oxidative Stress in Patients With Type II Diabetes and Insulin Resistance Undergoing Elective PTCA. A Randomized Double-blinded Phase II Study.
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effects of pioglitazone, once daily (QD), on heart functioning before, during and after stent implantation.
Detailed Description:
Type 2 diabetes increases the risk of coronary heart disease at least by two to three fold compared with non-diabetic subjects. Moreover, prospective studies have shown a significant correlation between several glycemic confounders and morbidity from coronary heart disease even in patients without diabetes mellitus. In patients with previously diagnosed coronary heart disease, impaired glucose tolerance was found in 30 to 67 %. The cardiovascular risk of patients with insulin resistance, with or without glucose intolerance has become more and more apparent within recent years and quantitative coronary angiographic studies have revealed a correlation between the severity of coronary heart disease and impaired glucose tolerance.
A new pharmaceutical class for the intervention of insulin resistance, the peroxisome proliferator activated receptor (gamma) agonists have been successfully introduced in the treatment of type 2 diabetes. Beyond their metabolic effects on glucose and lipid metabolism, peroxisome proliferator activated receptor (gamma) agonists show to exert a couple of pleiotropic, anti-inflammatory and vasoprotective effects in patients with type 2 diabetes and impaired glucose tolerance.
The incidence and severity of peri-procedural myocardial injury during percutaneous coronary interventions with stent implantation in diabetic and in non-diabetic patients is an important prognostic confounder for the patient. Different laboratory biomarkers have been investigated as diagnostic tools for the estimation of the risk of peri-procedural myocardial injury. Recent studies have convincingly demonstrated that the risk of subsequent ischemic heart events is related to the extent of cardiac troponin or CK-MB increase after coronary intervention, and the prognosis for these individuals is usually worse than that for patients who do not develop an increase in these biomarkers.
In a recent trial it was shown that pretreatment with atorvastatin could reduce procedural myocardial injury in elective coronary intervention. The incidence of Troponin I increase was 48% in the placebo group compared to 20% in the atorvastatin group.
The aim of this study is to investigate the effect of pioglitazone on the incidence of peri-procedural myocardial injury in patients undergoing percutaneous coronary interventions with stent implantation. Total participation time is anticipated to be 3 weeks.
A new pharmaceutical class for the intervention of insulin resistance, the peroxisome proliferator activated receptor (gamma) agonists have been successfully introduced in the treatment of type 2 diabetes. Beyond their metabolic effects on glucose and lipid metabolism, peroxisome proliferator activated receptor (gamma) agonists show to exert a couple of pleiotropic, anti-inflammatory and vasoprotective effects in patients with type 2 diabetes and impaired glucose tolerance.
The incidence and severity of peri-procedural myocardial injury during percutaneous coronary interventions with stent implantation in diabetic and in non-diabetic patients is an important prognostic confounder for the patient. Different laboratory biomarkers have been investigated as diagnostic tools for the estimation of the risk of peri-procedural myocardial injury. Recent studies have convincingly demonstrated that the risk of subsequent ischemic heart events is related to the extent of cardiac troponin or CK-MB increase after coronary intervention, and the prognosis for these individuals is usually worse than that for patients who do not develop an increase in these biomarkers.
In a recent trial it was shown that pretreatment with atorvastatin could reduce procedural myocardial injury in elective coronary intervention. The incidence of Troponin I increase was 48% in the placebo group compared to 20% in the atorvastatin group.
The aim of this study is to investigate the effect of pioglitazone on the incidence of peri-procedural myocardial injury in patients undergoing percutaneous coronary interventions with stent implantation. Total participation time is anticipated to be 3 weeks.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: