The Effect of Point-of-care Platelet Function Assay Guided Antiplatelet Therapy on the Periprocedural Increase of Cardiac Enzymes.
Overview
- Phase
- Phase 4
- Intervention
- Abciximab
- Conditions
- Diabetes Mellitus
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Peak cardiac enzyme level (CK-MB,troponin-I)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The researchers aimed to investigate the effect of point-of-care platelet function assay on the periprocedural cardiac enzyme elevation in patients with diabetes mellitus.
All patients who are supposed to undergo coronary angiography were loaded with clopidogrel (300mg) and aspirin (300mg) at D-1. If patients were determined to implant coronary stent after diagnostic coronary angiography, their platelet function is assayed with Verifynow-ADP (Accumetrics). If patients have >270 unit in the assay, they are randomized to abciximab or control group. After successful stent implantation, cardiac enzymes (CK-MB, Troponin-I) are followed at 8hr, 16hr and 24hr. Clinical outcomes including bleeding complications are assessed at 1 month.
Investigators
Dong-Ju Choi
Associate Professor
Seoul National University Bundang Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients who were determined to implant drug-eluting coronary stent
- •Diabetes mellitus (type 1 or 2)
Exclusion Criteria
- •Age \<18 years or \>80years
- •Patients with acute myocardial infarction
- •Patients with history of cerebral hemorrhage ever or ischemic infarction within 2 years
- •Patients with history of major surgery (abdominal, thoracic, intraocular) within 6 months
- •Patients who have have allergy to antiplatelet medications (aspirin, clopidogrel, abciximab)
- •Patients who are on anticoagulation therapy
- •Serum creatinine \>2.0mg/dl or ALT/AST \> 3 times of upper normal limit (120 U/L)
Arms & Interventions
abciximab
Intervention: Abciximab
control
Intervention: control
Outcomes
Primary Outcomes
Peak cardiac enzyme level (CK-MB,troponin-I)
Time Frame: within 24 hrs
The investigators will check cardiac enzymes at 8hrs, 16hrs and 24hrs after percutaneous coronary intervention. We will take the highest value among those measured at three time points as a patient's peak cardiac enzyme level. The primary outcome of this study is to compare the peak cardiac enzyme level between two groups.
Secondary Outcomes
- major adverse cardiovascular events (MACE): a composite of cardiac death, myocardial infarction, ischemic stroke(1 month)
- Bleeding complications (cerebrovascular, intraocular, bleeding which needs transfusion more than 2 pints)(1 month)
- The rate of periprocedural myocardial infarction(8hr, 16hr, 24hrs)