Effect of pioglitazone on cardiovascular events in high-risk diabetic patients with acute brain infarction

UMIN ID: UMIN000001112

Registered date:04/04/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Acute brain infarction with type2 diabetes mellitus.
• Date of first enrollment: 2008/03/01
• Target sample size: 600
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention: oral administration of pioglitazone 15mg per day.
Control: no use of thiazolidine derivatives.

Outcome(s)

• Primary Outcome: Cardiovascular events (death, stroke, acute coronary syndrome). Recurrence of brain infarction.
• Secondary Outcome: Improvement of neurological deficits, ADL, cognitive functions, asymptomatic brain lesions, and progression of carotid lesions. Biochemical markers.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: History of congestive heart failure (in case of suspicious patients, BNP>100 or ejection fraction less than 40%). Administration of thiazolidine derivatives prior to onset. History of adverse reaction to thiazolidine derivatives liver dysfunction (hepatitis due to HBV, HCV, alcohol or increased titer of ALT exceeding 3 times of normal value). Renal dysfunction (Cr>2.5). HbA1c>9%. Requirement for long-term insulin therapy (exclude temporary use of insulin). Brain infarction due to unclassified causes such as dissection, moyamoya disease, etc. Regarded as inadequate to entry for the study.

Related Information

• Primary Sponsor: Kyushu University
• Source(s) of Monetary Support: None