Prevention of Instent Renarrowing With Aggressive Glucose Lowering With Pioglitazone in Diabetic Patients
Status:
Completed
Trial end date:
2007-03-01
Target enrollment:
Participant gender:
Summary
Patients with diabetes have worse outcomes after percutaneous coronary intervention (PCI)
procedures, compared to those patients without diabetes. They are at increased risk of death,
heart attack, or needing further procedures due to renarrowing of their coronary narrowings
after implantation of a coronary stent. Studies have suggested that poor control of diabetes
may be partly responsible for these poor outcomes. Thiazolidinedione drugs, such as
pioglitazone, can improve the diabetes control and make the patient more sensitive to the
effects of insulin. Preliminary studies suggest that pioglitazone may also help prevent
renarrowing after PCI.
This study was a pilot study designed to determine whether more aggressive treatment of the
diabetes with the routine use of the drug pioglitazone (30mg/day for 6 months), in addition
to the patient's usual diabetic medications adjusted to optimize their diabetic control (get
glycated hemoglobin < 7%), could reduce the amount of tissue buildup within the stent after 6
months, compared to a group less aggressively treated without pioglitazone and their usual
medications for diabetes.
An intravascular ultrasound probe was used to assess the extent of tissue buildup within the
stent and this was performed immediately after the PCI as a baseline and repeated after 6
months of therapy.
The investigators hypothesize that the more aggressive diabetic treatment with pioglitazone
would reduce the extent of tissue growth within the stent after 6 months of therapy.