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Extended Treatment with Statin on Atheroma Regression Evaluated by Intravascular Ultrasound with Virtual Histology (Extended TRUTH Study)

Extended Treatment with Statin on Atheroma Regression Evaluated by Intravascular Ultrasound with Virtual Histology (Extended TRUTH Study) - Extended TRUTH Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004627
Enrollment
119
Registered
2010-11-26
Start date
2010-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with stable angina or unstable angina

Interventions

Sponsors

Kanagawa PTCA Conference
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Among subjects registered for the TRUTH Study, patients (FAS subjects) available for baseline and follow-up measurement of coronary artery plaque using VH-IVUS gave consent to participate in this research

Exclusion criteria

Exclusion criteria: 1)Patients meeting the contraindications or relative contraindications for pitavastatin and pravastatin 2)Patients with hepatic disorder or with AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limits of normal 3)Patients with renal dysfunction(serum creatinine 2.0mg/dL or higher) 4)Patients with a history of severe muscular disorder or with CK(CPK) greater than 2.5 times of the upper limit of normal 5)Patients with acute myocardial infarction occurred within 24 hours 6)Patients having failed to PCI 7)Patients with cerebrovascular accident occurred within 1 month 8)Patients with concurrent or a history of malignant tumor within 5 years prior to start of the investigationak drug 9)Patients receiving LDL apheresis 10)Patients with homozygous familial hypercholesterolemia 11)Patients requiring the following prohibited concomitant drugs 12)Drug abusers 13)Patients participating in other studies 14)Patients ineligible for the study determined by doctors

Design outcomes

Primary

MeasureTime frame
Change in component of coronary artery plaque measured by VH-IVUS

Secondary

MeasureTime frame
1)Vessel volume, Lumen volume, Plaque volume 2)Cardiovascular composite events (cardiovascular death, nonfatal myocardial infarction, nonfatal cerebral infarction, unstable angina, revascularization except target lesion revascularization) 3)change of serum lipid (TC, LDL-C, TG, HDL-C) 4)others marker (hs-CRP)

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026