(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention)

Study Overview
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Brief Summary
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The hypothesis: Low dose intracoronary unfractionated heparin is as effective and safe as standard dose intravenous unfractionated heparin on patients with elective percutaneous coronary intervention.

Detailed Description
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Aim: Primary objective:To evaluate the efficiency and safety of low dose intracoronary unfractioned heparin (UFH) on elective percutaneous coronary intervention (PCI). Secondary objective: To evaluate the effect of low dose intracoronary UFH on myocardial ischemia after PCI. To evaluate the effect of low dose intracoronary UFH on bleeding complications after PCI. To evaluate the cost-effectivity of low dose intracoronary UFH on elective PCI Study central: Bursa Postgraduate Hospital, Cardiology Clinic Study population: we planned to enrol 200 patients. Patients will randomise in two groups (control group:100 patients, study group:100 patients) Study works:-Write case report form for all patients Control for inclusion criteria Demographic data (age, gender) Height, weight, BMI and glomerular filtration rate (GFR) Risk factors laboratory data (biochemical and hematologic) Medication history Echocardiographic data Angiographic data Procedure time PCI data(vessel diameter, stent diameter, lesion and stent length, performed percutaneous transluminal coronary angioplasty (PTCA) or not, etc) Before and after procedure (activated clotting time) ACT value Before and after procedure troponin I (TnI) and Creatine kinase MB (CKMB) levels Note complication (MACE, bleeding, hematoma etc) Note femoral compression time. 4 weeks later note the first control data. Six months later note the second control data.

Official Title
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A RandomisED StUdy Comparing Standard Systemic Anticoagulation ThErapy to Low Dose Intracoronary Anticoagulation Therapy for Elective Percutaneous Coronary Intervention

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients; who have planned elective PCI and have had written informed consent for participation to study. The native coronary artery; lesion with narrowing >=70%, lesion without thrombus no left main coronary artery (LMCA) lesion no chronic total occlusion lesion Exclusion Criteria: Patients have allergy for acetylsalicylic acid (ASA), Clopidogrel and heparin Patients who performed primary PCI Patients with acute coronary syndrome Patients with have a history of myocardial infarction (MI) for two weeks Patients who were use UFH or low molecular weight heparin (LMWH) for 24 hours Patients on warfarin therapy Patients who have bleeding diathesis, or have high risk for bleeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose intracoronary heparin<br>Low dose intracoronary heparin: In this group elective coronary intervention was performed with low dose intracoronary Heparin | Other: coronary intervention<br>* elective coronary intervention<br>|
| Active Comparator: Standard treatment arm<br>Standard treatment arm: In this group elective coronary intervention performed with standard dose intravenous heparin | Other: coronary intervention<br>* elective coronary intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events |  | 30 days | 
| Major Adverse Cardiac Event |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous coronary intervention, low dose intracoronary heparin