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

NCT01475552 | Completed Phase 4 DMC

• 1 other identifier: DM-Verifynow
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

platelet reactivity; platelet function assay; abciximab; tailored therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  8hr, 16hr, 24hrs

Study Arms (2)

abciximab

EXPERIMENTAL

Drug: Abciximab

control

ACTIVE COMPARATOR

Drug: control

Interventions

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).

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

abciximab

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

Also known as: Aspirin, Clopidogrel (Plavix)

control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were determined to implant drug-eluting coronary stent
• Diabetes mellitus (type 1 or 2)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Abciximab; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dong-Ju Choi, MD,PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 21, 2011
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 13, 2012

Record last verified: 2012-12

Locations

KR (1)