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

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01475552

Collaborator

(none)

130

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: Abciximab Drug: control	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: abciximab

Drug: Abciximab

Patients, who showed PRU >270 unit and were randomized to abciximab group,were treated with abciximab in addition to conventional antiplatelet treatment (aspirin+clopidogrel).

Other Names:

*Reopro, Lily Korea

Dose: 0.25mg/kg intravenous bolus injection and 0.125ug/kg/min continuous infusion for 12hrs

Active Comparator: control

Drug: control

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

Other Names:

Aspirin

Clopidogrel (Plavix)

Outcome Measures

Primary Outcome Measures

Peak cardiac enzyme level (CK-MB,troponin-I) [within 24 hrs]
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.

Secondary Outcome Measures

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 [8hr, 16hr, 24hrs]
The definition of periprocedural myocardial infarction : cardiac enzyme increase more than three times of upper normal limit

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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)