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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong-Ju Choi, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01475552
First received: November 14, 2011
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Diabetes Mellitus
Drug: Abciximab
Drug: control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Peak cardiac enzyme level (CK-MB,troponin-I) [ Time Frame: within 24 hrs ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Bleeding complications (cerebrovascular, intraocular, bleeding which needs transfusion more than 2 pints) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • The rate of periprocedural myocardial infarction [ Time Frame: 8hr, 16hr, 24hrs ] [ Designated as safety issue: No ]
    The definition of periprocedural myocardial infarction : cardiac enzyme increase more than three times of upper normal limit


Enrollment: 130
Study Start Date: September 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475552

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

No publications provided

Responsible Party: Dong-Ju Choi, Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01475552     History of Changes
Other Study ID Numbers: DM-Verifynow
Study First Received: November 14, 2011
Last Updated: December 12, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Bundang Hospital:
platelet reactivity
platelet function assay
abciximab
tailored therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Abciximab
Clopidogrel
Anticoagulants
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014