Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection

December 5, 2014 updated by: University of California, San Diego
Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

20 patients with cervicocephalic arterial dissection will be randomized to open-label aspirin or warfarin, rate of stroke and adverse events will be endpoints.

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 Medical Center

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:

  • Clinical and imaging diagnosis of cervicocephalic arterial dissection within 3 months.

Exclusion Criteria:

  • Any contraindication to aspirin or warfarin.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aspirin
Drug: aspirin
Experimental: warfarin
Drug: warfarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of stroke by one year.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrent dissection by one year.
Time Frame: 1 year
1 year
Incidence of TIA by one year.
Time Frame: 1 year
1 year
Incidence of major and minor bleeding episodes by one year.
Time Frame: 1 year
1 year

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

December 1, 2005

Study Completion (Anticipated)

March 1, 2007

Study Registration Dates

First Submitted

December 12, 2005

First Submitted That Met QC Criteria

December 12, 2005

First Posted (Estimate)

December 14, 2005

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCSD IRB #051253

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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