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| ID | Type | Description | Link |
|---|---|---|---|
| IRB#0996-007 FUND#7810 | Other Identifier | Northwestern Memorial Hospital |
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The purpose of this study is to determine if PFA results correlate with ischemic event outcomes as well as bleeding complications. Hypothesis is antiplatelet agents will be more efficacious if they are administered in a dose-adjusted manner using PFA results as a guide.
Atherothrombotic disease is a leading killer of adults throughout the world. The current mainstay for the prevention of ischemic vascular events is the use of aspirin Antiplatelet agents are used routinely for the primary and secondary prevention of vascular events in patients with a prior history of stroke, TIA, or at high risk for the development of cerebrovascular disease. Numberous individual studies and meta-analyses have shown that essentially all of the oral antiplatelet agents have limited efficacy, with relative risk reductions in the range of 20-35%. The purpose of this study is to perform serial platelet function assays (PFAs) on patients with cerebrovascular disease who are taking antiplatelet agents and perform a pilot study to determine the feasibility of administering ASA as a dose adjusted medication using PFA. The long term goal of this study is to determine whether antiplatelet therapy will be more efficacious and/or safer if it is administered in a dose-adjusted manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel 75 mg | Active Comparator | Clopidogrel 75 mg daily |
|
| Aspirin 81 mg | Active Comparator | open-label Aspirin 81 mg daily |
|
| Aspirin > 300mg | Active Comparator | open-label Aspirin over 300 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | Clopidogrel 75 mg QD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| PFA1 | Platelet Function Analysis (PFA) lab results: PFA was performed using the PFA 100 device (Dade-Behring), which uses a higher sheer stress flow cytometry paradigm to measure the time in seconds to closing of an aperture. Normal is defined as <172 seconds." | 3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months) |
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Inclusion Criteria:
Exclusion Criteria:
-None
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| Name | Affiliation | Role |
|---|---|---|
| Mark J Alberts, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8784113 | Background | Taylor TN, Davis PH, Torner JC, Holmes J, Meyer JW, Jacobson MF. Lifetime cost of stroke in the United States. Stroke. 1996 Sep;27(9):1459-66. doi: 10.1161/01.str.27.9.1459. |
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Patients with cerebrovascular disease and taking one or more antiplatelet medication were consented for study participation from 2007 though 2010. Patients were recruiting on the inpatient stroke unit at Northwestern Memorial Hospital and seen in the outpatient stroke clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clopidogrel 75 mg | Clopidogrel 75 mg QD |
| FG001 | Aspirin 81 mg | Aspirin 81 mg QD |
| FG002 | Aspirin > 300 mg | Aspiring > 300 mg QD |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clopidogrel 75 mg | Clopidogrel 75 mg QD |
| BG001 | Aspirin 81 mg | Aspirin 81 mg QD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | PFA1 | Platelet Function Analysis (PFA) lab results: PFA was performed using the PFA 100 device (Dade-Behring), which uses a higher sheer stress flow cytometry paradigm to measure the time in seconds to closing of an aperture. Normal is defined as <172 seconds." | Posted | Mean | Standard Error | seconds | 3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months) |
|
Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
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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 75 mg | Clopidogrel 75 mg QD |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinical Stroke | Vascular disorders | Systematic Assessment | one patient suffered a clinical stroke |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nose bleeds | Vascular disorders | Systematic Assessment | 4 patients suffered from nose bleeds |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Northwestern University | Northwestern University | 312.503.4394 | r-bernstein@northwestern.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Aspirin 81 mg | Drug | Aspirin 81mg QD |
|
|
| Aspirin >300 mg | Drug | Aspirin >300 mg QD |
|
|
| BG002 |
| Aspiring >300 mg |
Aspirin >300 mg QD |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
open-label Aspirin |
|
|
|
| 0 |
| 15 |
| 2 |
| 15 |
| EG001 | Aspirin 81 mg | Aspirin 81 mg QD | 1 | 32 | 3 | 32 |
| EG002 | Aspirin >300 mg | Aspirin >300 mg QD | 2 | 46 | 2 | 46 |
|
| MI | Cardiac disorders | Systematic Assessment | one patient suffered a MI |
|
| TIA | Vascular disorders | Systematic Assessment | one patient suffered from a TIA |
|
|
| Bruising | Immune system disorders | Systematic Assessment | minor bruising |
|
| GI bleeding | Gastrointestinal disorders | Systematic Assessment | minor GI bleeding/blood in stool |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |