Pilot Study of Aspirin Versus Warfarin for Cervicocephali... | NCT00265408

Studies
Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection

NCT00265408

Sponsor

University of California, San Diego

Status

Withdrawn

Last Update Posted

Dec 8, 2014Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Ischemic Stroke

Interventions

aspirin
warfarin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Not provided

Completion Date

Mar 2007Estimated

First Submitted Date

Dec 12, 2005

First Submission Date that Met QC Criteria

Dec 12, 2005

First Posted Date

Dec 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2014

Last Update Posted Date

Dec 8, 2014Estimated

Description Module

Brief Summary

Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
aspirin	Experimental		Drug: aspirin
warfarin	Experimental		Drug: warfarin

Name	Type	Description	Arm Group Labels	Other Names
aspirin	Drug		aspirin
warfarin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of stroke by one year.		1 year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Any contraindication to aspirin or warfarin.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matt B Jensen, MD	UCSD Stroke Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSD Medical Center		San Diego	California	92103	United States

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001241	Aspirin
D014859	Warfarin

Ancestor Terms

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided