NCT01668901

Brief Summary

In this study, the investigators examine whether aspirin or warfarin is useful for atrial fibrillation patients with chronic kidney disease.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2012

Typical duration for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

August 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

August 1, 2012

Enrollment Period

3 years

First QC Date

August 16, 2012

Last Update Submit

October 24, 2016

Conditions

Atrial FibrillationChronic Kidney Disease

Keywords

warfarinaspirin

Outcome Measures

Primary Outcomes (1)

  • Thromboembolic event

    Ischemis stroke and systemic thromboembolism

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Major bleeding

    through study completion, an average of 1 year

Study Arms (2)

warfarin

EXPERIMENTAL

medication

Drug: warfarin

aspirin

ACTIVE COMPARATOR

medication

Drug: Aspirin

Interventions

warfarinDRUG

anticoagulation

warfarin
AspirinDRUG

antiplatelet

aspirin

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CHADS2 score 1 nonvalvular atrial fibrillation patients with chronic kidney disease

You may not qualify if:

  • HAS-BLED ≥30
  • History of syncope or seizure within 1 year
  • History of major bleeding event within 6 months
  • BP\>180/100
  • Abnormal prothrombin time
  • Hypersensitivity of aspirin or warfarin
  • Folstein mini mental state examination score \<26
  • Taking or had taken other anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Nationap University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Atrial FibrillationRenal Insufficiency, Chronic

Interventions

WarfarinAspirin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Seil Oh, MD,PhD

    Seoul National University Hospital, Seoul , Korea

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

August 16, 2012

First Posted

August 20, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2015

Study Completion

June 1, 2016

Last Updated

October 25, 2016

Record last verified: 2012-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)