Pravastatin for Acute Myocardial Infarction With Minimally to Mildly Increased Levels of Serum Cholesterol Study (PRACTIC)
Primary Purpose
Acute Myocardial Infarction
Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Pravastatin
Sponsored by
About this trial
This is an interventional prevention trial for Acute Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
the presence of 2 of the following 3 criteria:
- a clinical history of central chest oppression, pain, or tightness lasting for ≥30 minutes
- 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)
- an increase in the serum creatine kinase levels to >2 times the normal laboratory value.
- the serum level of LDL-C is ≥70 and 130> mg/dl in the first blood examination soon after admission
Exclusion Criteria:
- concurrent therapy with any HMG-CoA reductase inhibitor
- previous history of the side effects associated with any HMG-CoA reductase inhibitor
- life-threatening arrhythmia
- severe chronic congestive heart failure
- hepatic dysfunction
- renal failure
- cerebrovascular disease
- poor controlled diabetes
- pregnancy, lactation
- age <20 years
- disability of taking medicine or absence of a written informed consent
- Patients whom the doctors consider inappropriate by any other reason
Sites / Locations
- Kansai Rosai HospitalRecruiting
- Higashi-Osaka City General HospitalRecruiting
- Kawachi General HospitalRecruiting
- Osaka Minami Medical Center, National Hospital OrganizationRecruiting
- Osaka Rosai HospitalRecruiting
- Osaka University HospitalRecruiting
- Osaka General Medical Center
- Osaka Police HospitalRecruiting
- Sakurabashi Watanabe Hospital
Outcomes
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.
Secondary Outcome Measures
Each component of the primary outcome measures.
Full Information
NCT ID
NCT00688922
First Posted
May 29, 2008
Last Updated
November 28, 2008
Sponsor
Osaka Acute Coronary Insufficiency Study Group
1. Study Identification
Unique Protocol Identification Number
NCT00688922
Brief Title
Pravastatin for Acute Myocardial Infarction With Minimally to Mildly Increased Levels of Serum Cholesterol Study
Acronym
PRACTIC
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Osaka Acute Coronary Insufficiency Study Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pravastatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the presence of 2 of the following 3 criteria:
a clinical history of central chest oppression, pain, or tightness lasting for ≥30 minutes
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)
an increase in the serum creatine kinase levels to >2 times the normal laboratory value.
the serum level of LDL-C is ≥70 and 130> mg/dl in the first blood examination soon after admission
Exclusion Criteria:
concurrent therapy with any HMG-CoA reductase inhibitor
previous history of the side effects associated with any HMG-CoA reductase inhibitor
life-threatening arrhythmia
severe chronic congestive heart failure
hepatic dysfunction
renal failure
cerebrovascular disease
poor controlled diabetes
pregnancy, lactation
age <20 years
disability of taking medicine or absence of a written informed consent
Patients whom the doctors consider inappropriate by any other reason
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasuhiko Sakata, MD/PhD
Phone
81-6-6879-6612
Email
sakatayk@medone.med.osaka-u.ac.jp
Facility Information:
Facility Name
Kansai Rosai Hospital
City
Amagasaki
State/Province
Hyogo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shinsuke Nanto, MD/PhD
Phone
81-6-6416-1221
First Name & Middle Initial & Last Name & Degree
Shinnsuke Nanto, MD/PhD
Facility Name
Higashi-Osaka City General Hospital
City
Higashi-Osaka
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshiyuki Kijima, MD/PhD
First Name & Middle Initial & Last Name & Degree
Yoshiyuki Kijima, MD/PhD
Facility Name
Kawachi General Hospital
City
Higashi-Osaka
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masayoshi Mishima, MD/PhD
First Name & Middle Initial & Last Name & Degree
Masayoshi Mishima, MD/PhD
Facility Name
Osaka Minami Medical Center, National Hospital Organization
City
Kawachinagano
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatsuya Sasaki, MD/PhD
First Name & Middle Initial & Last Name & Degree
Tatsuya Sasaki, MD/PhD
Facility Name
Osaka Rosai Hospital
City
Sakai
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masami Nishino, MD/PhD
First Name & Middle Initial & Last Name & Degree
Masami Nishino, MD/PhD
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasuhiko Sakata, MD/PhD
Phone
81-6-6879-6612
Email
sakatayk@medone.med.osaka-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Yasuhiko Sakata, MD/PhD
Facility Name
Osaka General Medical Center
City
Osaka
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masatake Fukunami, MD/PhD
First Name & Middle Initial & Last Name & Degree
Masatake Fukunami, MD/PhD
Facility Name
Osaka Police Hospital
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasunori Ueda, MD/PhD
Phone
81-6-6771-6051
First Name & Middle Initial & Last Name & Degree
Yasunori Ueda, MD/PhD
Facility Name
Sakurabashi Watanabe Hospital
City
Osaka
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroshi Ito, MD/PhD
First Name & Middle Initial & Last Name & Degree
Motoo Date, MD/PhD
First Name & Middle Initial & Last Name & Degree
Hiroshi Ito, MD/PhD
First Name & Middle Initial & Last Name & Degree
Motoo Date, MD/PhD
12. IPD Sharing Statement
Learn more about this trial
Pravastatin for Acute Myocardial Infarction With Minimally to Mildly Increased Levels of Serum Cholesterol Study
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