Japanese Primary Prevention Project With Aspirin

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00225849
• Other study ID #: JPPP-05-07
• Secondary ID: MHLW2004-CV(Adul
• Status: Recruiting
• Phase: Phase 4
• First received: September 22, 2005
• Last updated: September 22, 2005
• Start date: March 2005
• Est. completion date: September 2010

Study information

• Verified date: September 2005
• Source: Ministry of Health, Labour and Welfare, Japan
• Contact: Yasuo Ikeda, MD
• Phone: +81-3-3353-1211
• Email: yikeda[@]sc.itc.keio.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

Drug:
• Aspirin

Locations

Country	Name	City	State
Japan	Keio University School of Medicine	Tokyo

Sponsors (3)

Lead Sponsor	Collaborator
Ministry of Health, Labour and Welfare, Japan	Bayer, Japan Heart Foundation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite event of cerebro/cardiovascular (CV) death, nonfatal cerebral stroke (of any cause) and nonfatal myocardial infarction (MI)
Secondary	CV death
Secondary	Non CV death
Secondary	Nonfatal cerebral stroke
Secondary	Nonfatal MI
Secondary	Angina pectoris
Secondary	Transient ischemic attack
Secondary	Arteriosclerotic disease requiring surgery or intervention
Secondary	Extracranial bleeding requiring transfusion or admission
Secondary	Severe side-effects that lead to interruption of the study medication.