(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention)

Bursa Postgraduate Hospital200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Coronary Artery Disease

Interventions

coronary interventionOTHER

elective coronary intervention

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, Turkey (Türkiye)

Outcomes

Primary Outcomes

Major Adverse Cardiac Events

Time frame: 30 days

Major Adverse Cardiac Event

Time frame: 30 days

Data from ClinicalTrials.gov

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