(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention)

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

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.

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.