NCT01031095

(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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Bursa Postgraduate Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	coronary intervention	elective coronary intervention

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-12-01
• Completion: 2010-06-01
• First posted: 2009-12-14
• Last updated: 2014-01-30
• Results posted: 2013-10-10

Locations

1 site across 1 country: Turkey (Türkiye)