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

Seoul National University

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus

Treatments

Drug: Abciximab

Drug: control

Study type

Interventional

Funder types

Other

Identifiers

NCT01475552

DM-Verifynow

Details and patient eligibility

About

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.

Enrollment

130 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)