NCT00225849

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 26, 2005

Status Verified

September 1, 2005

First QC Date

September 22, 2005

Last Update Submit

September 22, 2005

Conditions

HypertensionHyperlipidemiaDiabetes Mellitus

Keywords

AspirinPrimary prevention

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (9)

  • CV death

  • Non CV death

  • Nonfatal cerebral stroke

  • Nonfatal MI

  • Angina pectoris

  • +4 more secondary outcomes

Interventions

AspirinDRUG

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keio University School of Medicine

Tokyo, Tokyo, 160-8582, Japan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 30565155DERIVED

  • 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.

    PMID: 27165949DERIVED

  • 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.

    PMID: 25401325DERIVED

MeSH Terms

Conditions

HypertensionHyperlipidemiasDiabetes Mellitus

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Yasuo Ikeda, MD

    Keio University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasuo Ikeda, MD

CONTACT

+81-3-3353-1211yikeda@sc.itc.keio.ac.jp

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 22, 2005

First Posted

September 26, 2005

Study Start

March 1, 2005

Study Completion

September 1, 2010

Last Updated

September 26, 2005

Record last verified: 2005-09

Locations

JP(1)