(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention) (REDUCED)

Bursa Postgraduate Hospital

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Other: coronary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01031095

BYİEAH1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Low dose intracoronary heparin

Experimental group

Description:

Low dose intracoronary heparin: In this group elective coronary intervention was performed with low dose intracoronary Heparin

Treatment:

Other: coronary intervention

Standard treatment arm

Active Comparator group

Description:

Standard treatment arm: In this group elective coronary intervention performed with standard dose intravenous heparin

Treatment:

Other: coronary intervention