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poor recruitment and reduction in CT surgery support
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The design of the study will be randomized, double blind trial, which will examine the effects of addition of clopidogrel to current guideline recommended background therapy on lowering the incidence of graft stenosis after coronary artery bypass grafting compared to placebo.
The purpose of this study is to evaluate how well the combination of clopidogrel and aspirin lower the risk of clot forming in the bypass graft after open heart surgery. This combination has not yet been approved by the Food & Drug Administration (FDA) for treating clots in the bypass graft. However, the FDA has not objected to its use to study its safety and effectiveness. This study will enroll approximately 150 total subjects all of which will be at Brooke Army Medical Center/Wilford Hall Medical Center. The study will be for 52 weeks from the day of surgery.
After bypass surgery and inclusion criteria is met, subjects will be placed on aspirin 81 mg once daily and placebo once daily or aspirin 81 mg once daily and clopidogrel 75mg once daily to keep the bypass grafts open after surgery. There are no studies to date comparing the two study groups A CT scan of the heart will be done 2 weeks after surgery to see if the grafts are still open. At the end of the study, at 52-weeks mark, the subjects will undergo another heart scan to evaluate the bypass grafts and see if they are still open.
Subjects will be seen on a 3 months basis until the end of the study, unless deemed necessary to return earlier for follow up. Subjects will undergo blood draw for complete blood count as part of the follow up visits to assess for safety while on the current study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clopidogrel | Active Comparator | aspirin and clopidogrel |
|
| sugar pill | Placebo Comparator | aspirin and placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clopidogrel | Drug | clopidogrel 75mg daily by mouth daily for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone | Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Bleeding Between the Two Treatment Arms | 52 weeks | |
| Number of Major Adverse Cardiovascular Events With Combination Therapy | Number of major adverse cardiovascular events(angina, any thrombotic events, and myocardial infarction) with combination therapy with aspirin and clopidogrel vs. aspirin alone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmad M Slim, MD | Brooke Army Medical Center | Principal Investigator |
| Rachel Beck, MD | Brooke Army Medical Center | Study Chair |
| William Conner, MD | Brooke Army Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | San Antonio | Texas | 78234 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clopidogrel | aspirin and clopidogrel clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months |
| FG001 | Sugar Pill | aspirin and placebo sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Two active treatment groups
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| ID | Title | Description |
|---|---|---|
| BG000 | Clopidogrel | aspirin and clopidogrel clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months |
| BG001 | Sugar Pill | aspirin and placebo sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months |
| 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 | Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone | Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo | Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo | Posted | Number | occluded grafts | 52 weeks | grafts | Participants |
|
52 weeks
52 weeks events of bleeding ( TIMI Major and Minor)
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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 | aspirin and clopidogrel clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Number of Angina Events | Cardiac disorders | TIMI trials | Systematic Assessment | Number of angina events with combination therapy with aspirin and clopidogrel vs. aspirin alone |
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The study did not recruit enough patients due to strict exclusion criteria and low volume of consenting patients resulting in a sample size that was insufficient for power analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AHMAD M. SLIM, MD, LTC, MC | BROOKE ARMY MEDICAL CENTER | 210-916-4717 | AHMAD.SLIM@US.ARMY.MIL |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D000073893 | Sugars |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| sugar pill | Drug | sugar pill by mouth daily for 12 months |
|
|
| Aspirin | Drug | aspirin 81 mg daily by mouth for 12 months ( Standard of care in both arms) |
|
|
| 52 weeks |
| Number of Angina Events | Number of angina events with combination therapy with aspirin and clopidogrel vs. aspirin alone | 52 weeks |
| Number of Myocardial Infarction Events | Number of myocardial infarction events with combination therapy with aspirin and clopidogrel vs. aspirin alone | 52 weeks |
| Number of Thrombotic Events | Number of thrombotic events with combination therapy with aspirin and clopidogrel vs. aspirin alone | 52 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Gender distribution among groups | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
|
|
| Secondary | Incidence of Bleeding Between the Two Treatment Arms | Posted | Number | BLEEDING EVENTS | 52 weeks |
|
|
|
| Secondary | Number of Major Adverse Cardiovascular Events With Combination Therapy | Number of major adverse cardiovascular events(angina, any thrombotic events, and myocardial infarction) with combination therapy with aspirin and clopidogrel vs. aspirin alone | above is the total number of all events reported | Posted | Number | MACE Events over 52Wks | 52 weeks | All events | Participants |
|
|
|
| Secondary | Number of Angina Events | Number of angina events with combination therapy with aspirin and clopidogrel vs. aspirin alone | above is the total number of participants | Posted | Number | Angina Events over 52Wks | 52 weeks |
|
|
|
| Secondary | Number of Myocardial Infarction Events | Number of myocardial infarction events with combination therapy with aspirin and clopidogrel vs. aspirin alone | above is the total number of participants | Posted | Number | MI Events over 52Wks | 52 weeks |
|
|
|
| Secondary | Number of Thrombotic Events | Number of thrombotic events with combination therapy with aspirin and clopidogrel vs. aspirin alone | above is the total number of participants | Posted | Number | thrombotic Events over 52Wks | 52 weeks |
|
|
|
| 10 |
| 12 |
| 0 |
| 12 |
| EG001 | Sugar Pill | aspirin and placebo sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months | 6 | 8 | 0 | 12 |
|
| Number of Myocardial Infarction Events | Cardiac disorders | TIMI trials | Systematic Assessment | Number of myocardial infarction events with combination therapy with aspirin and clopidogrel vs. aspirin alone |
|
| Number of Thrombotic Events | Vascular disorders | TIMI trials | Systematic Assessment | Number of thrombotic events with combination therapy with aspirin and clopidogrel vs. aspirin alone |
|
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| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002241 | Carbohydrates |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |