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Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00265408
First Posted: December 14, 2005
Last Update Posted: December 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of California, San Diego
  Purpose
Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection.

Condition Intervention Phase
Ischemic Stroke Drug: aspirin Drug: warfarin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Incidence of stroke by one year. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Recurrent dissection by one year. [ Time Frame: 1 year ]
  • Incidence of TIA by one year. [ Time Frame: 1 year ]
  • Incidence of major and minor bleeding episodes by one year. [ Time Frame: 1 year ]

Enrollment: 0
Study Start Date: December 2005
Estimated Study Completion Date: March 2007
Arms Assigned Interventions
Experimental: aspirin Drug: aspirin
Experimental: warfarin Drug: warfarin

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Any contraindication to aspirin or warfarin.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265408


Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Matt B Jensen, MD UCSD Stroke Center
  More Information

ClinicalTrials.gov Identifier: NCT00265408     History of Changes
Other Study ID Numbers: UCSD IRB #051253
First Submitted: December 12, 2005
First Posted: December 14, 2005
Last Update Posted: December 8, 2014
Last Verified: March 2007

Keywords provided by University of California, San Diego:
Cervicocephalic Arterial Dissection

Additional relevant MeSH terms:
Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aspirin
Warfarin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticoagulants