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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Treatments: Abciximab; Antibodies, Monoclonal; Aspirin; Clopidogrel; Immunoglobulin Fab Fragments

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)