drugset / Trial / NCT01475552

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

NCT01475552

Phase 4 Completed 130 enrolled Seoul National University Bundang Hospital
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2010-09
Primary completion
2011-09
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Abciximab Monoclonal antibody 0.125 ug/kg Intravenous
Comparator Aspirin Small molecule 100 mg
Comparator Clopidogrel Small molecule 75 mg

Indications