Tailored Antiplatelet Therapy During Percutaneous Coronary Intervention in Patients With Diabetes Mellitus
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Point-of-care Platelet Function Assay Guided Antiplatelet Therapy on the Periprocedural Increase of Cardiac Enzymes.|
- Peak cardiac enzyme level (CK-MB,troponin-I) [ Time Frame: within 24 hrs ] [ Designated as safety issue: Yes ]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.
- major adverse cardiovascular events (MACE): a composite of cardiac death, myocardial infarction, ischemic stroke [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Bleeding complications (cerebrovascular, intraocular, bleeding which needs transfusion more than 2 pints) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- The rate of periprocedural myocardial infarction [ Time Frame: 8hr, 16hr, 24hrs ] [ Designated as safety issue: No ]The definition of periprocedural myocardial infarction : cardiac enzyme increase more than three times of upper normal limit
|Study Start Date:||September 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Patients, who showed PRU >270 unit and were randomized to abciximab group,were treated with abciximab in addition to conventional antiplatelet treatment (aspirin+clopidogrel).
|Active Comparator: control||
Patients,who showed PRU >270 unit and were randomized to control group,were treated with conventional antiplatelet therapy (aspirin+clopidogrel) during PCI and follow up periods.
Aspirin : D-1 300mg, D0-30 100mg qd Clopidogrel : D-1 300mg, D0-30 75mg qd
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475552
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam, Korea, Republic of|
|Principal Investigator:||Dong-Ju Choi, MD,PhD||Seoul National University Bundang Hospital|