search
Back to results

Pilot Study of Continuing Aspirin Versus Switching to Clopidogrel After Stroke or Transient Ischemic Attack

Primary Purpose

Transient Ischemic Attack, Stroke, Aspirin

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
aspirin versus clopidogrel
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Transient Ischemic Attack focused on measuring Transient ischemic attack, Stroke, Aspirin, Clopidogrel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 and older. Stroke or transient ischemic attack (TIA) while taking aspirin within one week of consent. Women of child-bearing potential will be included only if there is a negative pregnancy test and they agree to birth control during the treatment period. Exclusion Criteria: Any medical indication for a specific antiplatelet agent (aspirin, clopidogrel, ticlopidine, aggrenox), or an indication for a combination of antiplatelet agents. Any medical indication for anticoagulation, except subcutaneous heparin for deep vein thrombosis prophylaxis. Allergy to aspirin or clopidogrel.

Sites / Locations

  • UCSD Hillcrest
  • UCSD

Outcomes

Primary Outcome Measures

mRS at three months.

Secondary Outcome Measures

Incidence of stroke at three months, bleeding events.

Full Information

First Posted
August 10, 2006
Last Updated
July 31, 2019
Sponsor
University of California, San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT00363753
Brief Title
Pilot Study of Continuing Aspirin Versus Switching to Clopidogrel After Stroke or Transient Ischemic Attack
Official Title
Pilot Study of Continuing Aspirin Versus Switching to Clopidogrel After Stroke or Transient Ischemic Attack
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Diego

4. Oversight

5. Study Description

Brief Summary
Pilot study of continuing aspirin versus switching to clopidogrel after stroke or transient ischemic attack.
Detailed Description
Pilot study of continuing aspirin versus switching to clopidogrel after stroke or transient ischemic attack.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Ischemic Attack, Stroke, Aspirin, Clopidogrel
Keywords
Transient ischemic attack, Stroke, Aspirin, Clopidogrel

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
aspirin versus clopidogrel
Primary Outcome Measure Information:
Title
mRS at three months.
Secondary Outcome Measure Information:
Title
Incidence of stroke at three months, bleeding events.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 and older. Stroke or transient ischemic attack (TIA) while taking aspirin within one week of consent. Women of child-bearing potential will be included only if there is a negative pregnancy test and they agree to birth control during the treatment period. Exclusion Criteria: Any medical indication for a specific antiplatelet agent (aspirin, clopidogrel, ticlopidine, aggrenox), or an indication for a combination of antiplatelet agents. Any medical indication for anticoagulation, except subcutaneous heparin for deep vein thrombosis prophylaxis. Allergy to aspirin or clopidogrel.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matt B Jensen, MD
Organizational Affiliation
UCSD Stroke Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Hillcrest
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pilot Study of Continuing Aspirin Versus Switching to Clopidogrel After Stroke or Transient Ischemic Attack

We'll reach out to this number within 24 hrs