Aspirin Resistance and Percutaneous Coronary Intervention (PCI)

Phase 2

Completed

Interventions: Drug: Intravenous Glycoprotein inhibitor + ASA, Clopidogrel
Drug: Antiplatelet Therapy (ASA, Clopidogrel)

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Aggressive Strategy	Intravenous Glycoprotein inhibitor + ASA, Clopidogrel	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
Conventional Strategy	Antiplatelet Therapy (ASA, Clopidogrel)	Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.