NCT00027066

Brief Summary

The goal of this study is to compare aspirin to warfarin for the prevention of recurrent stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,206

participants targeted

Target at P75+ for phase_3 stroke

Timeline
Completed

Started Jun 1993

Longer than P75 for phase_3 stroke

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 1993

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2000

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2001

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2001

Completed
Last Updated

June 17, 2011

Status Verified

June 1, 2011

Enrollment Period

7 years

First QC Date

November 20, 2001

Last Update Submit

June 16, 2011

Conditions

Stroke

Keywords

strokeaspirinwarfarin

Study Arms (2)

Active Warfarin and Aspirin Placebo

ACTIVE COMPARATOR

One 2 mg scored tablet daily of Warfarin and one 325 mg tablet daily of aspirin placebo.

Drug: Active WarfarinDrug: Aspirin placebo

Active Aspirin and Warfarin Placebo

ACTIVE COMPARATOR

One 325 mg tablet daily of aspirin and one 2 mg scored tablet daily of Warfarin placebo.

Drug: Active AspirinDrug: Warfarin placebo

Interventions

Active AspirinDRUG

325mg tablet daily

Active Aspirin and Warfarin Placebo
Active WarfarinDRUG

2mg scored tablet daily

Active Warfarin and Aspirin Placebo
Aspirin placeboDRUG

325mg aspirin placebo pill

Active Warfarin and Aspirin Placebo
Warfarin placeboDRUG

2mg scored placebo tablet

Active Aspirin and Warfarin Placebo

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acceptable candidates for warfarin therapy
  • Had an ischemic stroke within the previous 30 days
  • Had scores of 3 or more on the Glasgow Outcome Scale

You may not qualify if:

  • Base-line INR above the normal range (more than 1.4)
  • History of stroke due to a procedure or that was attributed to high-grade carotid stenosis for which surgery was planned
  • History of stroke associated with an inferred cardioembolic source

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Health Sciences

New York, New York, 10032, United States

Location

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • J. P. Mohr, M.D.

    Columbia University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2001

First Posted

November 21, 2001

Study Start

June 1, 1993

Primary Completion

June 1, 2000

Study Completion

November 1, 2001

Last Updated

June 17, 2011

Record last verified: 2011-06

Locations

US(1)