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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475552
• Other study ID #: DM-Verifynow
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2011
• Last updated: December 12, 2012
• Start date: September 2010
• Est. completion date: October 2011

Study information

• Verified date: December 2012
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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).
• 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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	major adverse cardiovascular events (MACE): a composite of cardiac death, myocardial infarction, ischemic stroke		1 month	Yes
Secondary	Bleeding complications (cerebrovascular, intraocular, bleeding which needs transfusion more than 2 pints)		1 month	Yes
Secondary	The rate of periprocedural myocardial infarction	The definition of periprocedural myocardial infarction : cardiac enzyme increase more than three times of upper normal limit	8hr, 16hr, 24hrs	No