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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | All subjects will receive a 300 mg loading dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours after the administration of clopidotrel |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Coated Platelets After Coronary Angiography and/or PCI | The percentage of coated platelets 24 hours after coronary angiography and/or PCI | 6 hrs after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eliot Schechter, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, 1F187 | Oklahoma City | Oklahoma | 73104-5076 | United States |
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Patients scheduled for cardiac catheterization and possible percutaneous intervention who received a loading dose of 300 mg of clopidogrel were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clopidogrel Loading Dose | All subjects received a 300 mg loading dose of clopidogrel |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clopidogrel | All 27 subjects received a 300 mg loading dose of clopidogrel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Dec 2010 | Mean | Standard Deviation | Percent of platelets that are coated. | 24 hours after the administration of clopidotrel |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clopidogrel Loading Dose | All subjects received a 300 mg loading dose of clopidogrel |
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Limited to primarily Male VA population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eliot Schechter, MD | University of Oklahoma Health Sciences Center | 405-456-5378 | eliot-schechter@ouhsc.edu |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| The percentage of platelets that are "coated-Platelets" as measured by dual-agonist stimulation | In each patient the percentage of platelets that are collagen coated will be measured in each patient before clopidogrel administration. | Mean | Standard Deviation | percent coated platelets |
|
|
| 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 | Posted | Mean | Standard Deviation | Percentage of platelets that are coated | 6 hrs after procedure |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |