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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01031095
Recruitment Status : Completed
First Posted : December 14, 2009
Results First Posted : October 10, 2013
Last Update Posted : January 30, 2014
Information provided by (Responsible Party):
Hasan ARI, Bursa Postgraduate Hospital

December 11, 2009
December 14, 2009
January 21, 2012
October 10, 2013
January 30, 2014
June 2009
December 2009   (Final data collection date for primary outcome measure)
  • Major Adverse Cardiac Events [ Time Frame: 30 days ]
  • Major Adverse Cardiac Event [ Time Frame: 30 days ]
Death, MI or TVR revascularization within 30 days. [ Time Frame: 30 days ]
Complete list of historical versions of study NCT01031095 on Archive Site
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Major or minor bleeding according to TIMI criteria [ Time Frame: 30 days ]
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(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.


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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Coronary Artery Disease
Other: coronary intervention
elective coronary intervention
  • Experimental: Low dose intracoronary heparin
    Low dose intracoronary heparin: In this group elective coronary intervention was performed with low dose intracoronary Heparin
    Intervention: Other: coronary intervention
  • Active Comparator: Standard treatment arm
    Standard treatment arm: In this group elective coronary intervention performed with standard dose intravenous heparin
    Intervention: Other: coronary intervention

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2010
December 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Hasan ARI, Bursa Postgraduate Hospital
Bursa Postgraduate Hospital
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Study Director: Hasan Arı, MD Bursa Postgraduate Hospital
Bursa Postgraduate Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP