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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00265408
Other study ID # UCSD IRB #051253
Secondary ID
Status Withdrawn
Phase Phase 1
First received December 12, 2005
Last updated December 5, 2014
Start date December 2005
Est. completion date March 2007

Study information

Verified date March 2007
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Any contraindication to aspirin or warfarin.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
aspirin

warfarin


Locations

Country Name City State
United States UCSD Medical Center San Diego California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of stroke by one year. 1 year
Secondary Recurrent dissection by one year. 1 year
Secondary Incidence of TIA by one year. 1 year
Secondary Incidence of major and minor bleeding episodes by one year. 1 year
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