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
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Drug: Pravastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Osaka Acute Coronary Insufficiency Study Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: July 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688922

Contacts
Contact: Yasuhiko Sakata, MD/PhD 81-6-6879-6612 sakatayk@medone.med.osaka-u.ac.jp

Locations
Japan
Kansai Rosai Hospital Recruiting
Amagasaki, Hyogo, Japan
Contact: Shinsuke Nanto, MD/PhD    81-6-6416-1221      
Principal Investigator: Shinnsuke Nanto, MD/PhD         
Kawachi General Hospital Recruiting
Higashi-Osaka, Osaka, Japan
Contact: Masayoshi Mishima, MD/PhD         
Principal Investigator: Masayoshi Mishima, MD/PhD         
Higashi-Osaka City General Hospital Recruiting
Higashi-Osaka, Osaka, Japan
Contact: Yoshiyuki Kijima, MD/PhD         
Principal Investigator: Yoshiyuki Kijima, MD/PhD         
Osaka Minami Medical Center, National Hospital Organization Recruiting
Kawachinagano, Osaka, Japan
Contact: Tatsuya Sasaki, MD/PhD         
Principal Investigator: Tatsuya Sasaki, MD/PhD         
Osaka Rosai Hospital Recruiting
Sakai, Osaka, Japan
Contact: Masami Nishino, MD/PhD         
Principal Investigator: Masami Nishino, MD/PhD         
Osaka University Hospital Recruiting
Suita, Osaka, Japan, 565-0871
Contact: Yasuhiko Sakata, MD/PhD    81-6-6879-6612    sakatayk@medone.med.osaka-u.ac.jp   
Principal Investigator: Yasuhiko Sakata, MD/PhD         
Osaka General Medical Center Not yet recruiting
Osaka, Japan
Contact: Masatake Fukunami, MD/PhD         
Principal Investigator: Masatake Fukunami, MD/PhD         
Osaka Police Hospital Recruiting
Osaka, Japan
Contact: Yasunori Ueda, MD/PhD    81-6-6771-6051      
Principal Investigator: Yasunori Ueda, MD/PhD         
Sakurabashi Watanabe Hospital Not yet recruiting
Osaka, Japan
Contact: Hiroshi Ito, MD/PhD         
Contact: Motoo Date, MD/PhD         
Principal Investigator: Hiroshi Ito, MD/PhD         
Sub-Investigator: Motoo Date, MD/PhD         
Sponsors and Collaborators
Osaka Acute Coronary Insufficiency Study Group
  More Information

No publications provided

Responsible Party: Hiroshi Sato, Osaka University Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT00688922     History of Changes
Other Study ID Numbers: PRACTIC080703
Study First Received: May 29, 2008
Last Updated: November 28, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 11, 2014