Clinical trial NCT00225849: Japanese Primary Prevention Project With Aspirin
Official title: Japanese Primary Prevention Project With Aspirin in the Elderly With One or More Risk Factors of Vascular Events: JPPP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Hyperlipidemia
Diabetes Mellitus
Keywords: Aspirin
Primary prevention
Lead sponsor: Ministry of Health, Labour and Welfare, Japan
Sponsor class: OTHER_GOV
Collaborators: name: Japan Heart Foundation
name: Bayer
First posted: 2005-09-26
Enrollment: 10000
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

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 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.

Primary outcomes:
measure: Composite event of cerebro/cardiovascular (CV) death, nonfatal cerebral stroke (of any cause) and nonfatal myocardial infarction (MI)
Secondary outcomes:
measure: CV death
measure: Non CV death
measure: Nonfatal cerebral stroke
measure: Nonfatal MI
measure: Angina pectoris
measure: Transient ischemic attack
measure: Arteriosclerotic disease requiring surgery or intervention
measure: Extracranial bleeding requiring transfusion or admission
measure: Severe side-effects that lead to interruption of the study medication.
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Keio University School of Medicine
Study officials:
affiliation: Keio University
name: Yasuo Ikeda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.