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

Phase 4

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Abciximab; Drug: control

• Registration Number: NCT01475552
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-21
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-12
• Last Update Posted: 2012-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
abciximab	Abciximab	-
control	control	-

Primary Outcome Measures

Name	Time	Method
Peak cardiac enzyme level (CK-MB,troponin-I)	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

Name	Time	Method
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	The definition of periprocedural myocardial infarction : cardiac enzyme increase more than three times of upper normal limit

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of