Prevention of in-stent neointimal proliferation by Pioglitazone Study

UMIN ID: UMIN000000485

Registered date:13/09/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Type 2 diabetic patients with ischemic heart disease
• Date of first enrollment: 2003/07/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Control group: Patients are randomely asseigned to either control or Pioglitazone group. Control group can be treated with any medication except for Pioglitazone.
Intervention group: Patients are randomely asseigned to either control or intervention (Pioglitazone) group. Intervention group are treated with Pioglitazone (15-30mg).

Outcome(s)

• Primary Outcome: Angiographical restenosis and target lesion revascularization at 6 months follow-up
• Secondary Outcome: Neointimal volume assessed by intravascular ultrasound at 6months follow-up

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1).Severe liver or renal insufficiency(2).TIMI-flow grade <= 2 (3).Cardiogenic shock or congestive heart failure (4).Contraindication to antiplatelet therapy (5).Patient with gastrointestinal bleeding or transient ischemic attack (6).Ineligible for CABG (7). Ineligible for percutaneous coronary intervention

Related Information

• Primary Sponsor: Bell Land General Hospital
• Secondary Sponsor: Bell Land General Hospital Kobe General Hospital Osaka City General Hospital Osaka City University Medical School Fuchu Hospital
• Source(s) of Monetary Support: Oska City University Medical School, Division of Cardiology