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
Recruitment status was Recruiting
Sponsor:
Osaka Acute Coronary Insufficiency Study Group
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
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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:
Detailed Description:
-
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.
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:
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
Contacts and Locations
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 May 22, 2013