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Japanese Primary Prevention Project With Aspirin

Primary Purpose

Hypertension, Hyperlipidemia, Diabetes Mellitus

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Aspirin
Sponsored by
Ministry of Health, Labour and Welfare, Japan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Aspirin, Primary prevention

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Keio University School of MedicineRecruiting

Outcomes

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.

Full Information

First Posted
September 22, 2005
Last Updated
September 22, 2005
Sponsor
Ministry of Health, Labour and Welfare, Japan
Collaborators
Japan Heart Foundation, Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00225849
Brief Title
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

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2010 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ministry of Health, Labour and Welfare, Japan
Collaborators
Japan Heart Foundation, Bayer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hyperlipidemia, Diabetes Mellitus
Keywords
Aspirin, Primary prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aspirin
Primary Outcome Measure Information:
Title
Composite event of cerebro/cardiovascular (CV) death, nonfatal cerebral stroke (of any cause) and nonfatal myocardial infarction (MI)
Secondary Outcome Measure Information:
Title
CV death
Title
Non CV death
Title
Nonfatal cerebral stroke
Title
Nonfatal MI
Title
Angina pectoris
Title
Transient ischemic attack
Title
Arteriosclerotic disease requiring surgery or intervention
Title
Extracranial bleeding requiring transfusion or admission
Title
Severe side-effects that lead to interruption of the study medication.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasuo Ikeda, MD
Phone
+81-3-3353-1211
Ext
62421
Email
yikeda@sc.itc.keio.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasuo Ikeda, MD
Organizational Affiliation
Keio University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keio University School of Medicine
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasuo Ikeda, MD
Phone
+81-3-3353-1211
Ext
62421
Email
yikeda@sc.itc.keio.ac.jp
First Name & Middle Initial & Last Name & Degree
Yasuo Ikeda, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
30565155
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.
Results Reference
derived
PubMed Identifier
27165949
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. Erratum In: Stroke. 2018 Oct;49(10):e307.
Results Reference
derived
PubMed Identifier
25401325
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.
Results Reference
derived

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Japanese Primary Prevention Project With Aspirin

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