Trial record 1 of 4 for:    diabetes AND stroke risk AND Japanese adults
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Japanese Primary Prevention Project With Aspirin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Ministry of Health, Labour and Welfare, Japan.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Japan Heart Foundation
Bayer
Information provided by:
Ministry of Health, Labour and Welfare, Japan
ClinicalTrials.gov Identifier:
NCT00225849
First received: September 22, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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


Condition Intervention Phase
Hypertension
Hyperlipidemia
Diabetes Mellitus
Drug: Aspirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Japanese Primary Prevention Project With Aspirin in the Elderly With One or More Risk Factors of Vascular Events: JPPP

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Labour and Welfare, Japan:

Primary Outcome Measures:
  • Composite event of cerebro/cardiovascular (CV) death, nonfatal cerebral stroke (of any cause) and nonfatal myocardial infarction (MI)

Secondary Outcome Measures:
  • CV death
  • Non CV death
  • Nonfatal cerebral stroke
  • Nonfatal MI
  • Angina pectoris
  • Transient ischemic attack
  • Arteriosclerotic disease requiring surgery or intervention
  • Extracranial bleeding requiring transfusion or admission
  • Severe side-effects that lead to interruption of the study medication.

Estimated Enrollment: 10000
Study Start Date: March 2005
Estimated Study Completion Date: September 2010
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.

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225849

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

Locations
Japan
Keio University School of Medicine Recruiting
Tokyo, Japan, 160-8582
Contact: Yasuo Ikeda, MD    +81-3-3353-1211 ext 62421    yikeda@sc.itc.keio.ac.jp   
Principal Investigator: Yasuo Ikeda, MD         
Sponsors and Collaborators
Ministry of Health, Labour and Welfare, Japan
Japan Heart Foundation
Bayer
Investigators
Principal Investigator: Yasuo Ikeda, MD Keio University School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00225849     History of Changes
Other Study ID Numbers: JPPP-05-07, MHLW2004-CV(Adult disease)-010
Study First Received: September 22, 2005
Last Updated: September 22, 2005
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ministry of Health, Labour and Welfare, Japan:
Aspirin
Primary prevention

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperlipidemias
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on July 24, 2014