Prevention of Instent Renarrowing With Aggressive Glucose Lowering With Pioglitazone in Diabetic Patients

NCT00819325 | Completed Phase 4

• 2 other identifiers: NSHRF #404N-01NSHRF grant #404N-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Angina Pectoris; Type 2 Diabetes Mellitus; Percutaneous Coronary Intervention

Keywords

diabetes; stents; restenosis; thiazolidinediones; coronary atherosclerosis

Outcome Measures

Primary Outcomes (1)

• The primary IVUS endpoint of the study was the change in three-dimensional neointimal plaque volume within the stented segment at follow-up, compared to baseline.

  6 months

Secondary Outcomes (1)

• The secondary IVUS endpoint was the change in the two-dimensional NIA within the stent, using the cross-sectional slice showing the smallest LA on follow-up and comparing it to the corresponding baseline slice.

  6 months

Study Arms (2)

Intensive glycemic control

EXPERIMENTAL

Included routine use of pioglitazone (30 mg/d) for 6 months in addition to titration of their other oral hypoglycemic agents in order to get the HbA1c\<6%.

Drug: pioglitazone; Drug: oral hypoglycemic agents

conservative glycemic control

ACTIVE COMPARATOR

Included titration of oral hypoglycemic agents to get HbA1c\<7% without the use of a thiazolidinedione.

Drug: oral hypoglycemic agents

Interventions

pioglitazone DRUG

pioglitazone 30mg p.o. once a day for 6 months

Intensive glycemic control

oral hypoglycemic agents DRUG

sulfonylurea or metformin

Intensive glycemic control; conservative glycemic control

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between the ages 30 to 80 years
• had type 2 diabetes mellitus treated with diet or oral hypoglycemic agents (OHA: sulfonylurea or metformin alone or the combination of sulfonylurea or metformin as long as metformin dose was \< 2000 mg/d)
• All patients were undergoing either elective or urgent PCI of a de novo native coronary lesion (\> 70 % diameter stenosis) in a vessel ≥ 2.5 mm diameter that was felt to be suitable for stenting and an IVUS examination.

You may not qualify if:

• left main \> 50 % stenosis
• ongoing congestive heart failure or left ventricular ejection fraction \< 30%
• primary PCI for ST elevation MI
• use of insulin or thiazolidinedione therapy (rosiglitazone or pioglitazone) immediately before PCI
• known intolerance to thiazolidinediones
• creatinine \> 130 µmol/L
• significant liver disease: ALT or AST \> 3 times upper limit of normal, history of cirrhosis, or hepatitis
• women who were pregnant, breastfeeding, or childbearing potential

Sponsors & Collaborators

• Queen Elizabeth II Health Sciences Centre: lead
• Nova Scotia Health Research Foundation: collaborator

Study Sites (1)

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Pioglitazone; Hypoglycemic Agents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Lawrence M Title, MD FRCPC

  QE II Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 8, 2009
• Study Start: August 1, 2002
• Primary Completion: November 1, 2006
• Study Completion: March 1, 2007
• Last Updated: January 8, 2009

Record last verified: 2009-01

Locations

CA (1)