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Acute Myocardial InfarctionPhase 4PRACTICNCT00688922

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

A Phase 4 study testing Pravastatin in people with Acute Myocardial Infarction, run by Osaka Acute Coronary Insufficiency Study Group at 9 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Pravastatin
How many people
400 participants
Where
9 sitesJapan
Study dates
Jul 2008to Jun 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

Yasuhiko Sakata, MD/PhD contact

81-6-6879-6612

sakatayk@medone.med.osaka-u.ac.jp

9 sites in 1 country

Japan9 sites, 9 recruiting

  • Kansai Rosai Hospital

    Amagasaki, Hyōgo

    Shinsuke Nanto, MD/PhD, 81-6-6416-1221

    Shinnsuke Nanto, MD/PhD

    Recruiting

  • Higashi-Osaka City General Hospital

    Higashiosaka, Osaka

    Yoshiyuki Kijima, MD/PhD

    Yoshiyuki Kijima, MD/PhD

    Recruiting

  • Kawachi General Hospital

    Higashiosaka, Osaka

    Masayoshi Mishima, MD/PhD

    Masayoshi Mishima, MD/PhD

    Recruiting

  • Osaka Minami Medical Center, National Hospital Organization

    Kawachi-Nagano, Osaka

    Tatsuya Sasaki, MD/PhD

    Tatsuya Sasaki, MD/PhD

    Recruiting

  • Osaka General Medical Center

    Osaka, Osaka

    Masatake Fukunami, MD/PhD

    Masatake Fukunami, MD/PhD

    Not yet recruiting

  • Osaka Police Hospital

    Osaka, Osaka

    Yasunori Ueda, MD/PhD, 81-6-6771-6051

    Yasunori Ueda, MD/PhD

    Recruiting

  • Sakurabashi Watanabe Hospital

    Osaka, Osaka

    Hiroshi Ito, MD/PhD

    Motoo Date, MD/PhD

    Not yet recruiting

  • Osaka Rosai Hospital

    Sakai, Osaka

    Masami Nishino, MD/PhD

    Masami Nishino, MD/PhD

    Recruiting

  • Osaka University Hospital

    Suita, Osaka, 565-0871

    Yasuhiko Sakata, MD/PhD, 81-6-6879-6612, sakatayk@medone.med.osaka-u.ac.jp

    Yasuhiko Sakata, MD/PhD

    Recruiting

Other trials in Japan

About this study

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

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.

Read the 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.

Being tested
Pravastatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PravastatinDrug

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)

  1. Each component of the primary outcome measures.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJun 2010 (estimated)
  4. Study completionJun 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00688922
Sponsor's protocol ID
PRACTIC080703
Acronym
PRACTIC
Status last verified
Nov 2008
First submitted
29 May 2008
Last updated
2 Dec 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pravastatin in people with Acute Myocardial Infarction, run by Osaka Acute Coronary Insufficiency Study Group at 9 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yasuhiko Sakata, MD/PhD (81-6-6879-6612, sakatayk@medone.med.osaka-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00688922.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2008.

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