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Completed

NCT Number: NCT01475552

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Seongnam, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Abciximab

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).

Other names: *Reopro, Lily Korea, Dose: 0.25mg/kg intravenous bolus injection and 0.125ug/kg/min continuous infusion for 12hrs

Control

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

Other names: Aspirin, Clopidogrel (Plavix)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 21, 2011
Registry last updated
Dec 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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