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

Seoul National University Bundang Hospital130 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

130

Conditions

Diabetes Mellitus

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: within 24 hrs

Secondary Outcomes

major adverse cardiovascular events (MACE): a composite of cardiac death, myocardial infarction, ischemic stroke

Time frame: 1 month

Bleeding complications (cerebrovascular, intraocular, bleeding which needs transfusion more than 2 pints)

Time frame: 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

Time frame: 8hr, 16hr, 24hrs