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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pravastatin | Drug | 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. |
| Measure | Description | 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. | 20, 50 and 80% of the projected number of patients have been enrolled in the study |
| Measure | Description | Time Frame |
|---|---|---|
| Each component of the primary outcome measures. | 20, 50 and 80% of the projected number of patients have been enrolled in the study |
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Inclusion Criteria:
the presence of 2 of the following 3 criteria:
the serum level of LDL-C is ≥70 and 130> mg/dl in the first blood examination soon after admission
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasuhiko Sakata, MD/PhD | Contact | 81-6-6879-6612 | sakatayk@medone.med.osaka-u.ac.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansai Rosai Hospital | Recruiting | Amagasaki | Hyōgo | Japan |
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| Higashi-Osaka City General Hospital | Recruiting | Higashiosaka | Osaka | Japan |
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| Kawachi General Hospital | Recruiting | Higashiosaka | Osaka | Japan |
|
| Osaka Minami Medical Center, National Hospital Organization | Recruiting | Kawachi-Nagano | Osaka | Japan |
|
| Osaka General Medical Center | Not yet recruiting | Osaka | Osaka | Japan |
|
| Osaka Police Hospital | Recruiting | Osaka | Osaka | Japan |
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| Sakurabashi Watanabe Hospital | Not yet recruiting | Osaka | Osaka | Japan |
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| Osaka Rosai Hospital | Recruiting | Sakai | Osaka | Japan |
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| Osaka University Hospital | Recruiting | Suita | Osaka | 565-0871 | Japan |
|
| ID | Term |
|---|---|
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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