Chest Pain, Coronary Artery Disease
Conditions
Keywords
Platelets, platelet aggregation inhibitors
Brief 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.
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.
Interventions
DRUGClopidogrel
All subjects will receive a 300 mg loading dose
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients given clopidogrel loading dose before scheduled catheterization or percutaneous intervention
Exclusion criteria
* Acute coronary syndrome * Unable to tolerate clopidogrel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty | 24 hours after the administration of clopidotrel | The percentage of platelets that are collagen coated after the administration of clopidogrel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Coated Platelets After Coronary Angiography and/or PCI | 6 hrs after procedure | The percentage of coated platelets 24 hours after coronary angiography and/or PCI |
Countries
United States
Participant flow
Recruitment details
Patients scheduled for cardiac catheterization and possible percutaneous intervention who received a loading dose of 300 mg of clopidogrel were recruited.
Participants by arm
| Arm | Count |
|---|---|
| Clopidogrel All 27 subjects received a 300 mg loading dose of clopidogrel | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Clopidogrel |
|---|---|
| Age Continuous | 64 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 25 Participants |
| The percentage of platelets that are coated-Platelets as measured by dual-agonist stimulation | 40.0 percent coated platelets STANDARD_DEVIATION 14.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
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.
Time frame: 24 hours after the administration of clopidotrel
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clopidogrel Loading Dose | The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty | 32.8 Percent of platelets that are coated. | Standard Deviation 13.6 |
Secondary
The Percentage of Coated Platelets After Coronary Angiography and/or PCI
The percentage of coated platelets 24 hours after coronary angiography and/or PCI
Time frame: 6 hrs after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clopidogrel Loading Dose | The Percentage of Coated Platelets After Coronary Angiography and/or PCI | 33.9 Percentage of platelets that are coated | Standard Deviation 12.3 |