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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01475552
Recruitment Status : Completed
First Posted : November 21, 2011
Last Update Posted : December 13, 2012
Information provided by (Responsible Party):
Dong-Ju Choi, Seoul National University Bundang Hospital

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

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Study Type : Interventional  (Clinical Trial)
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 : September 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Abciximab

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)

Primary Outcome Measures :
  1. Peak cardiac enzyme level (CK-MB,troponin-I) [ Time Frame: 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 :
  1. major adverse cardiovascular events (MACE): a composite of cardiac death, myocardial infarction, ischemic stroke [ Time Frame: 1 month ]
  2. Bleeding complications (cerebrovascular, intraocular, bleeding which needs transfusion more than 2 pints) [ Time Frame: 1 month ]
  3. The rate of periprocedural myocardial infarction [ Time Frame: 8hr, 16hr, 24hrs ]
    The definition of periprocedural myocardial infarction : cardiac enzyme increase more than three times of upper normal limit

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01475552

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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Sponsors and Collaborators
Seoul National University Bundang Hospital
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Principal Investigator: Dong-Ju Choi, MD,PhD Seoul National University Bundang Hospital

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Responsible Party: Dong-Ju Choi, Associate Professor, Seoul National University Bundang Hospital Identifier: NCT01475552     History of Changes
Other Study ID Numbers: DM-Verifynow
First Posted: November 21, 2011    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: December 2012
Keywords provided by Dong-Ju Choi, Seoul National University Bundang Hospital:
platelet reactivity
platelet function assay
tailored therapy
Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents