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The objective of this study is to evaluate if aggressive antiplatelet therapy would reduce ischemic events in aspirin (ASA) resistant patients after percutaneous coronary intervention (PCI).
This is the first US based randomized double blinded prospective study using triple antiplatelet therapy and double dose plavix maintenance dose in aspirin resistant patients undergoing elective PCI through femoral access. The primary outcome of this study is an elevation of cardiac enzymes within 24 hours after the PCI with a secondary outcome of a composite of major adverse cardiac events of death, MI, stent thrombosis and urgent revascularization and bleeding up to 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Strategy | Other | Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure |
|
| Aggressive Strategy | Active Comparator | Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Glycoprotein inhibitor + ASA, Clopidogrel | Drug | IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Elevation of Cardiac Enzyme | Number of participants with peri-procedural biomarker elevation defined as any elevation above baseline of CK-MB or Tn-I within 24 hours after completion of the procedure. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Adverse Cardiac Event (MACE) | Number of participants with MACE which is any event of Death, MI, Stent Thrombosis, Urgent Revascularization, Bleeding. Major adverse cardiac events (MACE), defined as the composite of death, MI (CK-MB > 3 times normal), urgent revascularization and definite or probable stent thrombosis (ST) within 30 days. Stent thrombosis was defined according to the new academic research consortium definitions; 2) bleeding complications within 30 days. Major bleeding was defined as intracranial or intraocular bleeding or a drop in hemoglobin > 5 g/dL. Minor bleeding was defined as hemorrhage at the access site requiring intervention, hematoma with a diameter of at least 5 cm, a reduction in hemoglobin levels of at least 4 g/dL without an overt bleeding source or at least 3 g/dL with such a source, reoperation for bleeding or transfusion of a blood product. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annapoorna S Kini, MD MRCP | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
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330 patients were screened with 36 enrolled between April 2007 and December 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Strategy | Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure |
| FG001 | Aggressive Strategy | Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Strategy | Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure |
| BG001 | Aggressive Strategy | Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally |
| 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 | Number of Participants With Elevation of Cardiac Enzyme | Number of participants with peri-procedural biomarker elevation defined as any elevation above baseline of CK-MB or Tn-I within 24 hours after completion of the procedure. | Posted | Count of Participants | Participants | 24 hours |
|
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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 | Conventional Strategy | Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stent thrombosis | Cardiac disorders |
Small pilot study with a limited sample size and not powered to detect differences in individual ischemic endpoints. Study does not delineate an optimal dose of aspirin. Antiplatelet effect of aspirin may fluctuate in patients at the same dosage.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Annapoorna S Kini | Icahn School of Medicine at Mount Sinai | (212) 241-4181 | Annapoorna.Kini@mountsinai.org |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D003643 | Death |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| C117446 | cangrelor |
| D000077284 | Abciximab |
| D000077542 | Eptifibatide |
| D000077466 | Tirofiban |
| D058924 | Thienopyridines |
| D013988 | Ticlopidine |
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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| Antiplatelet Therapy (ASA, Clopidogrel) | Drug | Standard antiplatelet PCI treatment |
|
|
| 30 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Participants With Major Adverse Cardiac Event (MACE) | Number of participants with MACE which is any event of Death, MI, Stent Thrombosis, Urgent Revascularization, Bleeding. Major adverse cardiac events (MACE), defined as the composite of death, MI (CK-MB > 3 times normal), urgent revascularization and definite or probable stent thrombosis (ST) within 30 days. Stent thrombosis was defined according to the new academic research consortium definitions; 2) bleeding complications within 30 days. Major bleeding was defined as intracranial or intraocular bleeding or a drop in hemoglobin > 5 g/dL. Minor bleeding was defined as hemorrhage at the access site requiring intervention, hematoma with a diameter of at least 5 cm, a reduction in hemoglobin levels of at least 4 g/dL without an overt bleeding source or at least 3 g/dL with such a source, reoperation for bleeding or transfusion of a blood product. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 15 |
| 18 |
| EG001 | Aggressive Strategy | Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally | 0 | 18 | 0 | 18 | 4 | 18 |
| Urgent Vascularization | Cardiac disorders |
|
| Myocardial Infarction | Cardiac disorders |
|
| Major Bleeding | Blood and lymphatic system disorders |
|
| Minor Bleeding | Blood and lymphatic system disorders |
|
| Cardiac Enzyme Elevation: Troponin-I | Cardiac disorders |
|
| Cardiac Enzyme Elevation: CK-MB | Cardiac disorders |
|
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| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007140 | Immunoglobulin Fab Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010456 | Peptides, Cyclic |
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D010879 | Piperazines |