Transient Ischemic AttackPhase 1NCT00363753
Pilot Study of Continuing Aspirin Versus Switching to Clopidogrel After Stroke or Transient Ischemic Attack
A Phase 1 study testing aspirin versus clopidogrel in people with Transient Ischemic Attack and Stroke, run by University of California, San Diego at 2 sites in United States.
Trial summary
Pilot study of continuing aspirin versus switching to clopidogrel after stroke or transient ischemic attack. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transient Ischemic Attack, Stroke, Aspirin
- What is being tested?
- aspirin versus clopidogrel
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2006to Mar 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCSD Hillcrest
San Diego, California, 92103
UCSD
San Diego, California, 92103
About this study
Pilot study of continuing aspirin versus switching to clopidogrel after stroke or transient ischemic attack.
Read the detailed description
Pilot study of continuing aspirin versus switching to clopidogrel after stroke or transient ischemic attack.
- Conditions
- Transient Ischemic Attack, Stroke, Aspirin, Clopidogrel
- Being tested
- aspirin versus clopidogrel
- Keywords
- Transient ischemic attack, Stroke, Aspirin, Clopidogrel
- Medical subject headings
- Ischemic Attack, Transient, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin versus clopidogrelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
mRS at three months.
Secondary outcomes (1)
Incidence of stroke at three months, bleeding events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startAug 2006
- Study completionMar 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Ischemic AttackStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Matt B Jensen, MD, Principal investigator, UCSD Stroke Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363753
- Sponsor's protocol ID
- UCSD IRB #060452
- Status last verified
- Jul 2019
- First submitted
- 10 Aug 2006
- Last updated
- 2 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Continuing Aspirin Versus Switching to Clopidogrel After Stroke or Transient Ischemic Attack
- ClinicalTrials.gov ID
- NCT00363753
- Acronym / sponsor ID
- UCSD IRB #060452
- Conditions
- Transient Ischemic Attack, Stroke, Aspirin, Clopidogrel
- Keywords
- Transient ischemic attack, Stroke, Aspirin, Clopidogrel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Mar 2007 (estimated)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot study of continuing aspirin versus switching to clopidogrel after stroke or transient ischemic attack.
Detailed description
Pilot study of continuing aspirin versus switching to clopidogrel after stroke or transient ischemic attack.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirin versus clopidogrel | Drug | – |
Primary outcome
mRS at three months.
1 secondary outcome
Incidence of stroke at three months, bleeding events.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matt B Jensen, MD principal investigator
UCSD Stroke Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aspirin versus clopidogrel in people with Transient Ischemic Attack and Stroke, run by University of California, San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRS at three months.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.