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

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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Abciximab; Drug: control

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 24 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The definition of periprocedural myocardial infarction : cardiac enzyme increase more than three times of upper normal limit	8hr, 16hr, 24hrs

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: November 14, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (Estimate): November 21, 2011

Study Record Updates

• Last Update Posted (Estimate): December 13, 2012
• Last Update Submitted That Met QC Criteria: December 12, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: platelet function assay; abciximab; platelet reactivity; tailored therapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Anticoagulants; Clopidogrel; Abciximab
• Other Study ID Numbers: DM-Verifynow