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

Phase 4

• Conditions: Acute brain infarction with type2 diabetes mellitus.

• Registration Number: JPRN-UMIN000001112
• Lead Sponsor: Kyushu University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-04
• Study Completion: 2013-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular events (death, stroke, acute coronary syndrome). Recurrence of brain infarction.

Secondary Outcome Measures

Name	Time	Method
Improvement of neurological deficits, ADL, cognitive functions, asymptomatic brain lesions, and progression of carotid lesions. Biochemical markers.