(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention)

Phase 3

Completed

Conditions: Coronary Artery Disease

Interventions: Other: coronary intervention

Registration Number: NCT01031095

Lead Sponsor: Bursa Postgraduate Hospital

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose intracoronary heparin	coronary intervention	Low dose intracoronary heparin: In this group elective coronary intervention was performed with low dose intracoronary Heparin
Standard treatment arm	coronary intervention	Standard treatment arm: In this group elective coronary intervention performed with standard dose intravenous heparin

Primary Outcome Measures