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

NCT ID: NCT00688922

Last Updated: 2008-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Pravastatin

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Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Osaka Acute Coronary Insufficiency Study Group

OTHER

Sponsor Role lead

Responsible Party

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Osaka University Graduate School of Medicine

Locations

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Kansai Rosai Hospital

Amagasaki, Hyōgo, Japan

Site Status RECRUITING

Higashi-Osaka City General Hospital

Higashiosaka, Osaka, Japan

Site Status RECRUITING

Kawachi General Hospital

Higashiosaka, Osaka, Japan

Site Status RECRUITING

Osaka Minami Medical Center, National Hospital Organization

Kawachi-Nagano, Osaka, Japan

Site Status RECRUITING

Osaka General Medical Center

Osaka, Osaka, Japan

Site Status NOT_YET_RECRUITING

Osaka Police Hospital

Osaka, Osaka, Japan

Site Status RECRUITING

Sakurabashi Watanabe Hospital

Osaka, Osaka, Japan

Site Status NOT_YET_RECRUITING

Osaka Rosai Hospital

Sakai, Osaka, Japan

Site Status RECRUITING

Osaka University Hospital

Suita, Osaka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Yasuhiko Sakata, MD/PhD

Role: CONTACT

Phone: 81-6-6879-6612

Email: [email protected]

Facility Contacts

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Shinsuke Nanto, MD/PhD

Role: primary

Yoshiyuki Kijima, MD/PhD

Role: primary

Masayoshi Mishima, MD/PhD

Role: primary

Tatsuya Sasaki, MD/PhD

Role: primary

Masatake Fukunami, MD/PhD

Role: primary

Yasunori Ueda, MD/PhD

Role: primary

Hiroshi Ito, MD/PhD

Role: primary

Motoo Date, MD/PhD

Role: backup

Masami Nishino, MD/PhD

Role: primary

Yasuhiko Sakata, MD/PhD

Role: primary

Other Identifiers

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PRACTIC080703

Identifier Type: -

Identifier Source: org_study_id