PIoglitazone for PrEvention of Restenosis in Diabetic Patients
Recruitment status was: Recruiting
Restenosis requiring reintervention is still a limitation of percutaneous coronary angioplasty. Despite the use of Drug eluting stent (DES), the rate of restenosis remains 7% to 16% in diabetic patients, making it a challenging problem in interventional cardiology.
Still, in clinical trials, most of these attempts did not successfully limit neointimal formation after coronary stenting.
Thiazolidinediones (TZDs), like pioglitazone (pio) or rosiglitazone, are a novel class of oral antidiabetic agents currently used to treat patients with type 2 diabetes mellitus.
These agents increase insulin sensitivity and, as such, have favorable effects on blood glucose levels and the lipid profile in treated patients.
Beyond their metabolic action, TZDs have been shown to exhibit antiinflammatory and antiatherogenic effects in vascular cells in vitro and to limit lesion development in various animal models of arteriosclerosis.
Moreover, TZDs inhibit VSMC proliferation and migration, 2 critical processes in neointimal formation after coronary stenting.
Data from rodent models suggest that TZDs limit intimal proliferation after vascular injury, and in clinical studies with type 2 diabetic coronary artery disease (CAD) patients, TZDs have been shown to reduce neointimal formation as well as restenosis after coronary stent implantation.
Still, it remains unclear to what extend these effects depend on the metabolic action of these drugs and what might mainly be due to the improvement in glycemic control.
Recently a few reports on prevention of restenosis in type 2 diabetic patients (T2DM) with the use of TZDs as been published. All of them uses BMS as endoprosthetic devices. None of these evaluated the use of TZDs in combination with DES.
Aim of the study is to evaluate the efficacy of pioglitazone in prevention of in-stent restenosis after successful implantation of a sirolimus-eluting coronary stent for treatment of de-novo "complex" coronary vessel disease in patients with T2DM and stable coronary artery disease.
Study primary end-point are late-loss at 9 months.Secondary end-point include binary restenosis MACE at 1, 9 and 12 month, stent thrombosis at 12 months.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Prevention of Coronary Artery in STENT Restenosis With the Combined Use of Pioglitazone and Sirolimus-Eluting Coronary Stent|
- In-Segment Late Loss [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Binary restenosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- MACE [ Time Frame: 1, 9, 12 month ] [ Designated as safety issue: Yes ]
- Stent thrombosis [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||April 2011|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Pioglitazone
pioglitazone 30 mg/d
|Placebo Comparator: Placebo||
Placebo 30 mg/d
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376870
|Policlinico di Tor Vergata|
|Rome, Italy, 00133|
|Study Chair:||Francesco Romeo, MD||University of Rome Tor Vergata|