Coronary Artery DiseasePhase 4NCT00229528
Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease
A Phase 4 study testing Paxil-CR in people with Coronary Artery Disease, run by University of Oklahoma at 1 site in United States.
Trial summary
COAT-platelets stands for collagen and thrombin stimulated platelets, which are two things in the body that make platelets stick together. These platelets may be important in the initiation of a heart attack (myocardial infarction). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Paxil-CR
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to May 2006
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal volunteers (without heart disease)
- patients with heart disease
- between ages 18 \& 65
Who cannot join
- children less than 18 years
- adults greater than 65 years
- those who can not keep appointments
- patients within 2 weeks of a coronary catheterization
- patients within 6 months of unstable angina or myocardial infarction
- individuals with allergies to paroxetine or similar medications
Show all 19Show fewer
- individuals having adverse events to paroxetine or similar medications
- individuals with diagnosis of mania
- individuals with a diagnosis of hypomania
- individuals with a diagnosis of bipolar disorders
- individuals with a diagnosis of depression
- individuals with a diagnosis of panic disorders
- individuals with a diagnosis of seizure disorders
- individuals with a history of suicide attempts
- individuals with a diagnosis of hyponatremia
- individuals with active bleeding disorders
- individuals with a diagnosis of narrow angle glaucoma
- individuals with an estimated creatinine clearance of less that 30 ml/min
- individuals taking potentially interacting medications
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190
About this study
Official title: Dose Ranging Study of the Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease
COAT-platelets stands for collagen and thrombin stimulated platelets, which are two things in the body that make platelets stick together. These platelets may be important in the initiation of a heart attack (myocardial infarction). A chemical in the body called serotonin maybe responsible for COAT-platelet production. Paroxetine causes a significant reduction in platelet serotonin and therefore may have value in preventing heart attacks. Therefore, the current study is designed to determine whether paroxetine will decrease COAT-platelet production in normal volunteers and patients with cardiovascular disease.
- Conditions
- Coronary Artery Disease
- Being tested
- Paxil-CR
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paxil-CRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the percent COAT-platelet and response to Paxil-CR in 5 control subjects.
Secondary outcomes (1)
To define the percent COAT-platelet and response to Paxil-CR in 20 patients with Coronary Artery Disease.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Stephen F. Hamilton, Pharm.D., Principal investigator, The University of Oklahoma College of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229528
- Sponsor's protocol ID
- 1000774
- Status last verified
- Sep 2008
- First submitted
- 27 Sep 2005
- Last updated
- 22 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Ranging Study of the Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00229528
- Acronym / sponsor ID
- 1000774
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2004
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 29 Sep 2005 (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.
COAT-platelets stands for collagen and thrombin stimulated platelets, which are two things in the body that make platelets stick together. These platelets may be important in the initiation of a heart attack (myocardial infarction). A chemical in the body called serotonin maybe responsible for COAT-platelet production. Paroxetine causes a significant reduction in platelet serotonin and therefore may have value in preventing heart attacks. Therefore, the current study is designed to determine whether paroxetine will decrease COAT-platelet production in normal volunteers and patients with cardiovascular disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- normal volunteers (without heart disease)
- patients with heart disease
- between ages 18 \& 65
Key exclusion criteria (19 listed)
- children less than 18 years
- adults greater than 65 years
- those who can not keep appointments
- patients within 2 weeks of a coronary catheterization
- patients within 6 months of unstable angina or myocardial infarction
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 |
|---|---|---|
| Paxil-CR | Drug | – |
Primary outcome
To define the percent COAT-platelet and response to Paxil-CR in 5 control subjects.
1 secondary outcome
To define the percent COAT-platelet and response to Paxil-CR in 20 patients with Coronary Artery Disease.
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 22 Sep 2008.
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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.
Stephen F. Hamilton, Pharm.D. principal investigator
The University of Oklahoma College of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paxil-CR in people with Coronary Artery Disease, run by University of Oklahoma 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 19 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 22 Sep 2008. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To define the percent COAT-platelet and response to Paxil-CR in 5 control subjects.. 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 22 Sep 2008.