Stanford type B aortic dissection patients with normally hypotensive medical therapy and pitavastatin treatment effect.

UMIN ID: UMIN000000685

Registered date:01/06/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Stanford type B acute aortic dissection patients transported within 48 hours of symptom onset , adaptable normally hypotensive medical therapy.
• Date of first enrollment: 2007/06/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Standard hypotensive medical therapy with pitavastatin 2 mg daily for a period of 12 months
Standard hypotensive medical therapy for a period of 12 months

Outcome(s)

• Primary Outcome: Percent change and absolute change in the total diameter of the descending aorta (minor axis) by CT angiography
• Secondary Outcome: Percent change and absolute change in the following items (1)Threatened rupture (2)Surgical operation (3)Serum lipid profile (LDL-C, triglyceride, HDL-C) (4)Serum creatinine (5)Correlation with the total diameter of descending aorta (minor axis) and serum lipid profile or serum creatinine (6)All-cause mortalities (7)Evaluation of adverse events (8)Laboratory test abnormalities

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) Patients with the total diameter of descending aorta (minor axis) by CT angiography more than 50mm. (2) Marfan's syndrome patients (3) Patients with continuous pain. (4) Patients with unstable vital signs. (5) Patients with signs or symptoms of organ ischemia (6) Fasting serum levels of TC >/= 250 mg/dL. (7) Known hypersensitivity or history of clinically significant adverse reactions to any component of study drugs. (8) Patients with hepatopathy (ALT >/=100 IU/L) or biliary obstruction with the following conditions - acute hepatitis, acute exacerbation of chronic hepatitis, hepatic cirrhosis, hepatoma, jaundice. (9) Pregnant, possibly pregnant, or lactating. (10) Patients with significant renal dysfunction (serum creatinine >/= 2.0 mg/dL) or renal dialysis. (11) Patient who is judged by the investigator to be inappropriate for inclusion in the study.

Related Information

• Primary Sponsor: Cardiovascular Surgery, Tohoku University, Graduate School of Medicine
• Source(s) of Monetary Support: None