Tailored Antiplatelet Therapy During Percutaneous Coronary Intervention in Patients With Diabetes Mellitus

Study 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.

Official Title
-----------------
The Effect of Point-of-care Platelet Function Assay Guided Antiplatelet Therapy on the Periprocedural Increase of Cardiac Enzymes.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Abciximab
* Drug: control


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: abciximab<br> | Drug: Abciximab<br>* Patients, who showed PRU >270 unit and were randomized to abciximab group,were treated with abciximab in addition to conventional antiplatelet treatment (aspirin+clopidogrel).<br>* Other names: Dose: 0.25mg/kg intravenous bolus injection and 0.125ug/kg/min continuous infusion for 12hrs;|
| Active Comparator: control<br> | Drug: control<br>* 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<br>* Other names: Clopidogrel (Plavix);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak cardiac enzyme level (CK-MB,troponin-I) | 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. | within 24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The definition of periprocedural myocardial infarction : cardiac enzyme increase more than three times of upper normal limit | 8hr, 16hr, 24hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelet reactivity, platelet function assay, abciximab, tailored therapy