Coronary Artery DiseaseNCT00644657
The Effect of Clopidogrel on Coated-Platelets in Patients Undergoing Cardiac Catheterization
A study testing Clopidogrel in people with Coronary Artery Disease and Chest Pain, run by University of Oklahoma at 1 site in United States.
Trial summary
This study will explore the effect of clopidogrel on coated-platelets in patients who are given a loading dose before diagnostic catheterization or percutaneous coronary intervention. We hypothesis that clopidogrel will reduce the percentage of platelets that are coated and therefore more hypercoagulable. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronary Artery Disease, Chest Pain
- What is being tested?
- Clopidogrel
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Sep 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients given clopidogrel loading dose before scheduled catheterization or percutaneous intervention
Who cannot join
- Acute coronary syndrome
- Unable to tolerate clopidogrel
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, 1F187
Oklahoma City, Oklahoma, 73104-5076
About this study
This study will explore the effect of clopidogrel on coated-platelets in patients who are given a loading dose before diagnostic catheterization or percutaneous coronary intervention. We hypothesis that clopidogrel will reduce the percentage of platelets that are coated and therefore more hypercoagulable.
Read the detailed description
Platelet activity will be determined by light transmission aggregometry at baseline, after a 300 mg dose of clopidogrel and after the catheterization and/or angioplasty procedure. The change in the percentage of platelets that are coated platelets will be determined.
- Conditions
- Coronary Artery Disease, Chest Pain
- Being tested
- Clopidogrel
- Keywords
- Platelets, platelet aggregation inhibitors
- Medical subject headings
- Coronary Artery Disease, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Also called Plavix
All subjects will receive a 300 mg loading dose
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty
The percentage of platelets that are collagen coated after the administration of clopidogrel.
Measured: 24 hours after the administration of clopidotrel
Secondary outcomes (1)
The Percentage of Coated Platelets After Coronary Angiography and/or PCI
The percentage of coated platelets 24 hours after coronary angiography and/or PCI
Measured: 6 hrs after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startMar 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eliot Schechter, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644657
- Sponsor's protocol ID
- 13291
- Status last verified
- Sep 2011
- First submitted
- 24 Mar 2008
- Last updated
- 7 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Clopidogrel on Coated-Platelets in Patients Undergoing Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT00644657
- Acronym / sponsor ID
- 13291
- Conditions
- Coronary Artery Disease, Chest Pain
- Keywords
- Platelets, platelet aggregation inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 27 Mar 2008 (estimated)
- Results
- Posted 7 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will explore the effect of clopidogrel on coated-platelets in patients who are given a loading dose before diagnostic catheterization or percutaneous coronary intervention. We hypothesis that clopidogrel will reduce the percentage of platelets that are coated and therefore more hypercoagulable.
Detailed description
Platelet activity will be determined by light transmission aggregometry at baseline, after a 300 mg dose of clopidogrel and after the catheterization and/or angioplasty procedure. The change in the percentage of platelets that are coated platelets will be determined.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients given clopidogrel loading dose before scheduled catheterization or percutaneous intervention
Key exclusion criteria (2 listed)
- Acute coronary syndrome
- Unable to tolerate 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 |
|---|---|---|
| ClopidogrelAlso: PlavixAll subjects will receive a 300 mg loading dose | Drug | – |
Primary outcome
The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty
Time frame: 24 hours after the administration of clopidotrel
The percentage of platelets that are collagen coated after the administration of clopidogrel.
1 secondary outcome
The Percentage of Coated Platelets After Coronary Angiography and/or PCI
Time frame: 6 hrs after procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Eliot Schechter, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clopidogrel in people with Coronary Artery Disease and Chest Pain, 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 1 inclusion and 2 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 7 Oct 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty (time frame: 24 hours after the administration of clopidotrel). 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 7 Oct 2011.