Diabetes Mellitus
Conditions
Keywords
platelet reactivity, platelet function assay, abciximab, tailored therapy
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.
Interventions
DRUGAbciximab
Patients, who showed PRU \>270 unit and were randomized to abciximab group,were treated with abciximab in addition to conventional antiplatelet treatment (aspirin+clopidogrel).
DRUGcontrol
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
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak cardiac enzyme level (CK-MB,troponin-I) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | The definition of periprocedural myocardial infarction : cardiac enzyme increase more than three times of upper normal limit |
Countries
South Korea
Outcome results
None listed