Cardiovascular DiseasePhase 1NCT00935506
Ex Vivo Human Thrombosis Chamber Study
A Phase 1 study testing Clopidogrel and Aspirin in people with Cardiovascular Disease, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
Purpose of study is to evaluate a thrombosis chamber model Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Clopidogrel and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Oct 2009
- 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Subjects
- BMI 18-30 kg/m²
- Male ages 18-45
Who cannot join
- Significant acute or chronic illness
- History of abnormal bleeding or coagulation disorder, intracranial hemorrhage, or a family history of abnormal bleeding or coagulation disorder in a first degree relative under 50 years of age
- Easy bruising
- Smoking within 3 months prior to Day 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Experimental EX Vivo Thrombosis Chamber Model in Healthy Male Subjects
Purpose of study is to evaluate a thrombosis chamber model
- Conditions
- Cardiovascular Disease
- Being tested
- Clopidogrel, Aspirin
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Also called Plavix
Tablets, Oral, 75 mg, Once daily, 8 days
AspirinDrug
Tablets, Oral, 325 mg, Once daily, 8 days
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel + Aspirin | Experimental | Not described Receives: Drug: Clopidogrel; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate ex vivo thrombosis chamber model by assessing the effect of anti-platelet agents on thrombus formation
Measured: Period 2, Day 8
Secondary outcomes (3)
Assess variability of thrombosis chamber measurements
Measured: Period 1 and Period 2
Assess relationship between platelet aggregation and thrombus formation
Measured: Period 1 and Period 2
Safety and tolerability of multiple doses clopidogrel and aspirin
Measured: From Day 1 through Study Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935506
- Sponsor's protocol ID
- CV197-004
- Status last verified
- Apr 2010
- First submitted
- 8 Jul 2009
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Experimental EX Vivo Thrombosis Chamber Model in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00935506
- Acronym / sponsor ID
- CV197-004
- Conditions
- Cardiovascular Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 9 Jul 2009 (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.
Purpose of study is to evaluate a thrombosis chamber model
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel + Aspirin | Experimental | Drug: Clopidogrel, Drug: Aspirin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Subjects
- BMI 18-30 kg/m²
- Male ages 18-45
Key exclusion criteria (4 listed)
- Significant acute or chronic illness
- History of abnormal bleeding or coagulation disorder, intracranial hemorrhage, or a family history of abnormal bleeding or coagulation disorder in a first degree relative under 50 years of age
- Easy bruising
- Smoking within 3 months prior to Day 1
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 |
|---|---|---|
| ClopidogrelAlso: PlavixTablets, Oral, 75 mg, Once daily, 8 days | Drug | Clopidogrel + Aspirin |
| AspirinTablets, Oral, 325 mg, Once daily, 8 days | Drug | Clopidogrel + Aspirin |
Primary outcome
Evaluate ex vivo thrombosis chamber model by assessing the effect of anti-platelet agents on thrombus formation
Time frame: Period 2, Day 8
3 secondary outcomes
Assess variability of thrombosis chamber measurements
Time frame: Period 1 and Period 2
Assess relationship between platelet aggregation and thrombus formation
Time frame: Period 1 and Period 2
Safety and tolerability of multiple doses clopidogrel and aspirin
Time frame: From Day 1 through Study Discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clopidogrel and Aspirin in people with Cardiovascular Disease, run by Bristol-Myers Squibb at 1 site 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 4 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: finished, as of the sponsor's last update on 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate ex vivo thrombosis chamber model by assessing the effect of anti-platelet agents on thrombus formation (time frame: Period 2, Day 8). 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 23 Feb 2011.