AzTrials
AzTrials

HypertensionPhase 4NCT00225849

Japanese Primary Prevention Project With Aspirin

A Phase 4 study testing Aspirin in people with Hypertension and Hyperlipidemia, run by Ministry of Health, Labour and Welfare, Japan at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

The purpose of this study is to investigate the balance between the risks and benefits of primary prevention by Aspirin in elderly Japanese patients with one or more cerebro/cardiovascular risk factors Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Hypertension, Hyperlipidemia, Diabetes Mellitus
What is being tested?
Aspirin
How many people
10,000 participants
Where
1 siteJapan
Study dates
Mar 2005to Sep 2010
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 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Elderly patients not previously diagnosed to have any arteriosclerotic disease, including coronary artery disease or cerebrovascular disease, but meeting any one or more of the following criteria (or on medication for any one or more of the following conditions).
  • Hypertension: SBP ≥ 140 mmHg or DBP ≥ 90 mmHg
  • Hyperlipidemia: Hypercholesterolemia (total cholesterol ≥ 220 mg/dL or LDL cholesterol ≥ 140 mg/dL) or Hypertriglyceridemia (Triglycerides ≥ 150 mg/dL) or Low-HDL cholesterolemia (HDL cholesterol < 40 mg/dL)
  • Diabetes: Fasting morning blood glucose ≥ 126 mg/dL or casual blood glucose ≥ 200 mg/dL or blood glucose at 2 hrs in the 75-g glucose tolerance test ≥ 200 mg/dL, or HbA1c ≥ 6.5%
  • Age: 60 to 85 years
  • Patients who can give written consent for participation in the study

Who cannot join

  • Patients with a history of coronary artery disease or cerebrovascular disease (including transient ischemic attack)
  • Patients with arteriosclerotic disease requiring surgery or intervention
  • Patients who have or may have atrial fibrillation
  • Patients being treated with aspirin, other antiplatelet agents or anticoagulants
  • Patients using NSAIDs chronically
  • Patients with a history of hypersensitivity to aspirin or salicylic acid
Show all 11Show fewer
  • Patients with peptic ulcers
  • Patients with a bleeding tendency
  • Patients with serious blood abnormalities
  • Patients with aspirin-sensitive asthma or a history of the same
  • Patients who are otherwise judged by the investigator to be unsuitable for enrollment in the study.

Trial locations and contacts

1 site in 1 country.

Yasuo Ikeda, MD contact

+81-3-3353-1211 ext. 62421

yikeda@sc.itc.keio.ac.jp

Japan1 site, 1 recruiting

  • Keio University School of Medicine

    Tokyo, Tokyo, 160-8582

    Yasuo Ikeda, MD, +81-3-3353-1211 ext. 62421, yikeda@sc.itc.keio.ac.jp

    Yasuo Ikeda, MD

    Recruiting

Other trials in Japan

About this study

Official title: Japanese Primary Prevention Project With Aspirin in the Elderly With One or More Risk Factors of Vascular Events: JPPP

The purpose of this study is to investigate the balance between the risks and benefits of primary prevention by Aspirin in elderly Japanese patients with one or more cerebro/cardiovascular risk factors

Read the detailed description

Cerebro/cardiovascular (CV) death accounts for approximately 30% of total deaths in Japan and therefore it is important to establish a preventive treatment for CV events from the point of public health. The guidelines proposed by a joint study group centering on the Japanese Circulation Society, recommend administration of aspirin to patients with multiple risk factors for primary prevention of arteriosclerotic diseases. In addition, the 2002 AHA guidelines recommend use of aspirin in patients with a 10% or higher 10-year risk of CV events. However, these descriptions are founded on randomized, comparative study results and epidemiological data obtained outside Japan, while no epidemiological data are available in Japan that would allow prediction and selection of patients who could benefit from primary prevention with aspirin. Although the benefit of aspirin for secondary prevention has been proven in Japanese patients, the benefits of primary prevention are still controversial.

JPPP is a multicenter, open-label, centrally randomized, controlled trial. In total, 10,000 elderly patients with one or more CV risk factors (age 60-85 years combined with hypertension, hyperlipidemia, and/or diabetes) will be assigned to enteric-coated aspirin (100mg/day) or control. The primary endpoint is composite event of CV death, nonfatal stroke (of any cause) and nonfatal myocardial infarction.

Being tested
Aspirin
Keywords
Aspirin, Primary prevention
Medical subject headings
Hypertension, Hyperlipidemias, Diabetes Mellitus

What participants receive

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

What is being measured

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

  1. Composite event of cerebro/cardiovascular (CV) death, nonfatal cerebral stroke (of any cause) and nonfatal myocardial infarction (MI)

Secondary outcomes (9)

  1. CV death

  2. Non CV death

  3. Nonfatal cerebral stroke

  4. Nonfatal MI

  5. Angina pectoris

  6. Transient ischemic attack

  7. Arteriosclerotic disease requiring surgery or intervention

  8. Extracranial bleeding requiring transfusion or admission

  9. Severe side-effects that lead to interruption of the study medication.

Timeline

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

  1. First posted26 Sep 2005 (estimated)
  2. Study startMar 2005
  3. Study completionSep 2010

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
10,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00225849
Sponsor's protocol ID
JPPP-05-07
Other IDs
MHLW2004-CV(Adult disease)-010
Status last verified
Sep 2005
First submitted
22 Sep 2005
Last updated
26 Sep 2005
Results posted
No

Publications

  • Sugawara M, Goto Y, Yamazaki T, Teramoto T, Oikawa S, Shimada K, Uchiyama S, Ando K, Ishizuka N, Murata M, Yokoyama K, Uemura Y, Ikeda Y; Japanese Primary Prevention Project (JPPP) Study Group. Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Elderly Japanese Patients with Atherosclerotic Risk Factors: Subanalysis of a Randomized Clinical Trial (JPPP-70). Am J Cardiovasc Drugs. 2019 Jun;19(3):299-311. doi: 10.1007/s40256-018-0313-0.

    PubMed 30565155

  • Uchiyama S, Ishizuka N, Shimada K, Teramoto T, Yamazaki T, Oikawa S, Sugawara M, Ando K, Murata M, Yokoyama K, Minematsu K, Matsumoto M, Ikeda Y; JPPP Study Group. Aspirin for Stroke Prevention in Elderly Patients With Vascular Risk Factors: Japanese Primary Prevention Project. Stroke. 2016 Jun;47(6):1605-11. doi: 10.1161/STROKEAHA.115.012461. Epub 2016 May 10.

    PubMed 27165949

  • Ikeda Y, Shimada K, Teramoto T, Uchiyama S, Yamazaki T, Oikawa S, Sugawara M, Ando K, Murata M, Yokoyama K, Ishizuka N. Low-dose aspirin for primary prevention of cardiovascular events in Japanese patients 60 years or older with atherosclerotic risk factors: a randomized clinical trial. JAMA. 2014 Dec 17;312(23):2510-20. doi: 10.1001/jama.2014.15690.

    PubMed 25401325

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aspirin in people with Hypertension and Hyperlipidemia, run by Ministry of Health, Labour and Welfare, Japan at 1 site 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 6 inclusion and 11 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 26 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Yasuo Ikeda, MD (+81-3-3353-1211 ext. 62421, yikeda@sc.itc.keio.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite event of cerebro/cardiovascular (CV) death, nonfatal cerebral stroke (of any cause) and nonfatal myocardial infarction (MI). 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 NCT00225849, which also lists 3 linked publications.

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 26 Sep 2005.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in