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Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and Cardiovascular Event Assessments

NCT01173939 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10000

Last updated 2011-06-01

No results posted yet for this study

Summary

The study is being conducted to compare the effect of standard treatment (target LDL-C level: \<120 mg/dL (JASGL 2007 target level)) and intensive treatment (target LDL-C level: \<70 mg/dL) in the prevention of major adverse cardiac events (MACE) in hypercholesterolemia patients with concomitant type 2 diabetes and hypertension.

Conditions

Interventions

DRUG

Pravastatin

5 mg/day or 10 mg/day of pravastatin will be administered orally for 36 months, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of \<120 mg/dL (JASGL 2007 target level) as quickly as possible. (Maximum dose increase of pravastatin: 20 mg/day)

DRUG

Rosuvastatin

5 mg/day or 10 mg/day of rosuvastatin will be administered orally for 36 months based on the LDL-C level of the subject, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of \<70 mg/dL as quickly as possible. (Maximum dose increase to rosuvastatin: 20 mg/day)

Sponsors & Collaborators

  • Positive Trial Group

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-06-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01173939 on ClinicalTrials.gov