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

NCT ID: NCT01475552

Last Updated: 2012-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus

Keywords

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platelet reactivity platelet function assay abciximab tailored therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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abciximab

Group Type EXPERIMENTAL

Abciximab

Intervention Type DRUG

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

control

Group Type ACTIVE_COMPARATOR

control

Intervention Type DRUG

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

Interventions

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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).

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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*Reopro, Lily Korea Dose: 0.25mg/kg intravenous bolus injection and 0.125ug/kg/min continuous infusion for 12hrs Aspirin Clopidogrel (Plavix)

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong-Ju Choi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong-Ju Choi, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DM-Verifynow

Identifier Type: -

Identifier Source: org_study_id