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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Osaka Acute Coronary Insufficiency Study Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Osaka Acute Coronary Insufficiency Study Group
ClinicalTrials.gov Identifier:
NCT00688922
First received: May 29, 2008
Last updated: November 28, 2008
Last verified: November 2008

May 29, 2008
November 28, 2008
July 2008
June 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
The primary outcome measure (endpoints) is the combination of death, non-fetal myocardial infarction, unstable angina, and revascularization for the infarct related artery. [ Time Frame: 20, 50 and 80% of the projected number of patients have been enrolled in the study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00688922 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
The secondary endpoints are re-hospitalization due to other cardiac causes (except coronary revascularization anticipated before randomization) and non-fetal stroke. [ Time Frame: 20, 50 and 80% of the projected number of patients have been enrolled in the study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Pravastatin for Acute Myocardial Infarction With Minimally to Mildly Increased Levels of Serum Cholesterol Study
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Acute Myocardial Infarction
Drug: Pravastatin
Take an initial dose of pravastatin to start as 10mg/day, which is the recommended initial dose by Health, Labour and Welfare Ministry of Japan, and a diet counseling.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
June 2011
June 2010   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Yasuhiko Sakata, MD/PhD 81-6-6879-6612 sakatayk@medone.med.osaka-u.ac.jp
Japan
 
NCT00688922
PRACTIC080703
Yes
Hiroshi Sato, Osaka University Graduate School of Medicine
Osaka Acute Coronary Insufficiency Study Group
Not Provided
Not Provided
Osaka Acute Coronary Insufficiency Study Group
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP