Pravastatin for Acute Myocardial Infarction With Minimally to Mildly Increased Levels of Serum Cholesterol Study

Last updated: November 28, 2008
Sponsor: Osaka Acute Coronary Insufficiency Study Group
Overall Status: Trial Status Unknown

Phase

4

Condition

Heart Defect

Congestive Heart Failure

Myocardial Ischemia

Treatment

N/A

Clinical Study ID

NCT00688922
PRACTIC080703
  • Ages > 20
  • All Genders

Study Summary

The purpose of the Study is to determine whether early treatment with pravastatin can reduce adverse cardiac events in patients with acute myocardial infarction and minimally to mildly elevated serum Low Density Lipoprotein -Cholesterol (LDL-C) levels.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. the presence of 2 of the following 3 criteria:

  2. a clinical history of central chest oppression, pain, or tightness lasting for ≥30 minutes

  3. typical electrocardiographic changes (i.e., ST-segment elevation of >0.1 mV in ≥1limb or 2 precordial leads, ST-segment depression >0.1 mV in ≥2 leads, abnormal Qwaves, or T-wave inversion in ≥2 leads)

  4. an increase in the serum creatine kinase levels to >2 times the normal laboratoryvalue.

  5. the serum level of LDL-C is ≥70 and 130> mg/dl in the first blood examination soonafter admission

Exclusion

Exclusion Criteria:

  1. concurrent therapy with any HMG-CoA reductase inhibitor

  2. previous history of the side effects associated with any HMG-CoA reductase inhibitor

  3. life-threatening arrhythmia

  4. severe chronic congestive heart failure

  5. hepatic dysfunction

  6. renal failure

  7. cerebrovascular disease

  8. poor controlled diabetes

  9. pregnancy, lactation

  10. age <20 years

  11. disability of taking medicine or absence of a written informed consent

  12. Patients whom the doctors consider inappropriate by any other reason

Study Design

Total Participants: 400
Study Start date:
July 01, 2008
Estimated Completion Date:
June 30, 2011

Study Description

The investigators previously reported the beneficial effect of early use of low-dose pravastatin on major adverse cardiac events in patients with acute myocardial infarction and mild to moderate hypercholesterolemia in the OACIS-LIPID Study. The PRACTIC study is designed as the OACIS-LIPID II trial to determine whether early treatment with pravastatin can reduce adverse cardiac events in patients with acute myocardial infarction and minimally to mildly elevated serum Low Density Lipoprotein -Cholesterol (LDL-C) levels.

Connect with a study center

  • Kansai Rosai Hospital

    Amagasaki, Hyogo
    Japan

    Active - Recruiting

  • Higashi-Osaka City General Hospital

    Higashi-Osaka, Osaka
    Japan

    Active - Recruiting

  • Kawachi General Hospital

    Higashi-Osaka, Osaka
    Japan

    Active - Recruiting

  • Osaka Minami Medical Center, National Hospital Organization

    Kawachinagano, Osaka
    Japan

    Active - Recruiting

  • Osaka Rosai Hospital

    Sakai, Osaka
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Suita, Osaka 565-0871
    Japan

    Active - Recruiting

  • Osaka General Medical Center

    Osaka,
    Japan

    Site Not Available

  • Osaka Police Hospital

    Osaka,
    Japan

    Active - Recruiting

  • Sakurabashi Watanabe Hospital

    Osaka,
    Japan

    Site Not Available

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