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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hasan ARI, Bursa Postgraduate Hospital
ClinicalTrials.gov Identifier:
NCT01031095
First received: December 11, 2009
Last updated: December 24, 2013
Last verified: December 2013

December 11, 2009
December 24, 2013
June 2009
December 2009   (final data collection date for primary outcome measure)
  • Major Adverse Cardiac Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Major Adverse Cardiac Event [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Death, MI or TVR revascularization within 30 days. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01031095 on ClinicalTrials.gov Archive Site
Not Provided
Major or minor bleeding according to TIMI criteria [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
(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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Stabile E, Nammas W, Salemme L, Sorropago G, Cioppa A, Tesorio T, Ambrosini V, Campopiano E, Popusoi G, Biondi Zoccai G, Rubino P. The CIAO (Coronary Interventions Antiplatelet-based Only) Study: a randomized study comparing standard anticoagulation regimen to absence of anticoagulation for elective percutaneous coronary intervention. J Am Coll Cardiol. 2008 Oct 14;52(16):1293-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01031095
BYİEAH1
No
Hasan ARI, Bursa Postgraduate Hospital
Bursa Postgraduate Hospital
Not Provided
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