Stable Angina
Conditions
Keywords
Major Adverse Cardiovascular Event, MACE, Death, MI, CK MB greater 3x Normal, Urgent Revascularization, Stent Thrombosis, Bleeding
Brief summary
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).
Detailed description
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.
Interventions
DRUGIntravenous Glycoprotein inhibitor + ASA, Clopidogrel
IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally
DRUGAntiplatelet Therapy (ASA, Clopidogrel)
Standard antiplatelet PCI treatment
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age older than 18 years * Scheduled for elective or ad-hos PCI * Aspirin use daily for greater or equal to one week * Aspirin resistant (ARU greater than or equal to 550 on Verify Now-ASA
Exclusion criteria
* Pre-procedural elevation of cardiac biomarkers (CK-MB greater or equal to 10.4ng/dl or Tnl greater or equal to 0.4ng/dl * administration of any GP IIb/IIIa inhibitor, anticoagulation or lytic therapy in the previous 30 days * Ongoing bleeding or bleeding diathesis, contraindications for anticoagulation or increased bleeding risk or history of bleeding in the last eight weeks * Previous stroke or transient ischemic attack or any intracranial pathology in the last six months, major surgery or trauma within the previous six weeks * Platelet count less than hundred thousand per cubic millimeter or hematocrit \<33% or hemoglobin \<11 g per deciliter * Subjects who received full dose low molecular weight heparin within six hours prior to randomization * Allergy or intolerance to any of the study drugs or the presence of any serious comorbidity with life expectancy of ≤1year * Scheduled for saphenous vein graft intervention, chronic total occlusions or with impaired renal function (eGFR\<60ml/min) or patients who were taking anticoagulants or antiplatelet agents other than aspirin and clopidogrel or nonsteroidal anti-inflammatory drugs within two weeks before the PCI procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Elevation of Cardiac Enzyme | 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Adverse Cardiac Event (MACE) | 30 days | 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. |
Countries
United States
Participant flow
Recruitment details
330 patients were screened with 36 enrolled between April 2007 and December 2008
Participants by arm
| Arm | Count |
|---|---|
| Conventional Strategy Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure | 18 |
| 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 | 18 |
| Total | 36 |
Baseline characteristics
| Characteristic | Conventional Strategy | Aggressive Strategy | Total |
|---|---|---|---|
| Age, Continuous | 65.2 years STANDARD_DEVIATION 10 | 66.2 years STANDARD_DEVIATION 9 | 65.7 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 15 / 18 | 4 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
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.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Strategy | Number of Participants With Elevation of Cardiac Enzyme | 4 Participants |
| Aggressive Strategy | Number of Participants With Elevation of Cardiac Enzyme | 2 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.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Strategy | Number of Participants With Major Adverse Cardiac Event (MACE) | 5 Participants |
| Aggressive Strategy | Number of Participants With Major Adverse Cardiac Event (MACE) | 1 Participants |