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

NCT00688922 | Unknown Phase 4 DMC

• 1 other identifier: PRACTIC080703
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 9

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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Each component of the primary outcome measures.

  20, 50 and 80% of the projected number of patients have been enrolled in the study

Interventions

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osaka Acute Coronary Insufficiency Study Group: lead

Study Sites (9)

Kansai Rosai Hospital

Amagasaki, Hyōgo, Japan

RECRUITING

Higashi-Osaka City General Hospital

Higashiosaka, Osaka, Japan

RECRUITING

Kawachi General Hospital

Higashiosaka, Osaka, Japan

RECRUITING

Osaka Minami Medical Center, National Hospital Organization

Kawachi-Nagano, Osaka, Japan

RECRUITING

Osaka General Medical Center

Osaka, Osaka, Japan

NOT YET RECRUITING

Osaka Police Hospital

Osaka, Osaka, Japan

RECRUITING

Sakurabashi Watanabe Hospital

Osaka, Osaka, Japan

NOT YET RECRUITING

Osaka Rosai Hospital

Sakai, Osaka, Japan

RECRUITING

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

RECRUITING

MeSH Terms

Interventions

Pravastatin

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Yasuhiko Sakata, MD/PhD

CONTACT

81-6-6879-6612; sakatayk@medone.med.osaka-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 3, 2008
• Study Start: July 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2011
• Last Updated: December 2, 2008

Record last verified: 2008-11

Locations

JP (9)