Aspirin versus clopidogrel in Stroke and Transient Ischemic Attack and Aspirin - Clinical Trials Registry

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Drug: aspirin versus clopidogrel

Detailed Description

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

Study Type

Interventional

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - San Diego, California, United States, 92103
    - UCSD
  - San Diego, California, United States, 92103
    - UCSD Hillcrest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
mRS at three months.

Secondary Outcome Measures

Outcome Measure
Incidence of stroke at three months, bleeding events.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

Principal Investigator: Matt B Jensen, MD, UCSD Stroke Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (Anticipated)

March 1, 2007

Study Registration Dates

First Submitted

August 10, 2006

First Submitted That Met QC Criteria