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

November 28, 2008 updated by: Osaka Acute Coronary Insufficiency Study Group

Pravastatin for Acute Myocardial Infarction With Minimally to Mildly Increased Levels of Serum Cholesterol Study That Evaluates the Effects of Pravastatin for Acute Myocardial Infarction With LDL-Cholesterol Levels of 70-129 mg/dl

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan
        • Not yet recruiting
        • Osaka General Medical Center
        • Contact:
          • Masatake Fukunami, MD/PhD
        • Principal Investigator:
          • Masatake Fukunami, MD/PhD
      • Osaka, Japan
        • Recruiting
        • Osaka Police Hospital
        • Contact:
          • Yasunori Ueda, MD/PhD
          • Phone Number: 81-6-6771-6051
        • Principal Investigator:
          • Yasunori Ueda, MD/PhD
      • Osaka, Japan
        • Not yet recruiting
        • Sakurabashi Watanabe Hospital
        • Contact:
          • Hiroshi Ito, MD/PhD
        • Contact:
          • Motoo Date, MD/PhD
        • Principal Investigator:
          • Hiroshi Ito, MD/PhD
        • Sub-Investigator:
          • Motoo Date, MD/PhD
    • Hyogo
      • Amagasaki, Hyogo, Japan
        • Recruiting
        • Kansai Rosai Hospital
        • Contact:
          • Shinsuke Nanto, MD/PhD
          • Phone Number: 81-6-6416-1221
        • Principal Investigator:
          • Shinnsuke Nanto, MD/PhD
    • Osaka
      • Higashi-Osaka, Osaka, Japan
        • Recruiting
        • Higashi-Osaka City General Hospital
        • Contact:
          • Yoshiyuki Kijima, MD/PhD
        • Principal Investigator:
          • Yoshiyuki Kijima, MD/PhD
      • Higashi-Osaka, Osaka, Japan
        • Recruiting
        • Kawachi General Hospital
        • Contact:
          • Masayoshi Mishima, MD/PhD
        • Principal Investigator:
          • Masayoshi Mishima, MD/PhD
      • Kawachinagano, Osaka, Japan
        • Recruiting
        • Osaka Minami Medical Center, National Hospital Organization
        • Contact:
          • Tatsuya Sasaki, MD/PhD
        • Principal Investigator:
          • Tatsuya Sasaki, MD/PhD
      • Sakai, Osaka, Japan
        • Recruiting
        • Osaka Rosai Hospital
        • Contact:
          • Masami Nishino, MD/PhD
        • Principal Investigator:
          • Masami Nishino, MD/PhD
      • Suita, Osaka, Japan, 565-0871
        • Recruiting
        • Osaka University Hospital
        • Contact:
        • Principal Investigator:
          • Yasuhiko Sakata, MD/PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

    1. a clinical history of central chest oppression, pain, or tightness lasting for ≥30 minutes
    2. typical electrocardiographic changes (i.e., ST-segment elevation of >0.1 mV in ≥1 limb or 2 precordial leads, ST-segment depression >0.1 mV in ≥2 leads, abnormal Q waves, or T-wave inversion in ≥2 leads)
    3. an increase in the serum creatine kinase levels to >2 times the normal laboratory value.
  2. the serum level of LDL-C is ≥70 and 130> mg/dl in the first blood examination soon after admission

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combination of death, non-fatal myocardial infarction, unstable angina, coronary revascularization (except anticipated revascularization before randomization), non-fatal stroke and re-hospitalization due to heart failure or other cardiac causes.
Time Frame: 20, 50 and 80% of the projected number of patients have been enrolled in the study
20, 50 and 80% of the projected number of patients have been enrolled in the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Each component of the primary outcome measures.
Time Frame: 20, 50 and 80% of the projected number of patients have been enrolled in the study
20, 50 and 80% of the projected number of patients have been enrolled in the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osaka Acute Coronary Insufficiency Study Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

May 29, 2008

First Submitted That Met QC Criteria

June 2, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Estimate)

December 2, 2008

Last Update Submitted That Met QC Criteria

November 28, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRACTIC080703

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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