(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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Other: coronary intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A RandomisED StUdy Comparing Standard Systemic Anticoagulation ThErapy to Low Dose Intracoronary Anticoagulation Therapy for Elective Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by Bursa Postgraduate Hospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: June 2009
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose intracoronary heparin
Low dose intracoronary heparin: In this group elective coronary intervention was performed with low dose intracoronary Heparin
Other: coronary intervention
elective coronary intervention
Active Comparator: Standard treatment arm
Standard treatment arm: In this group elective coronary intervention performed with standard dose intravenous heparin
Other: coronary intervention
elective 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031095

Locations
Turkey
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Bursa, Turkey, 16320
Sponsors and Collaborators
Bursa Postgraduate Hospital
Investigators
Study Director: Hasan Arı, MD Bursa Postgraduate Hospital
  More Information

Publications:
Responsible Party: Hasan ARI, Bursa Postgraduate Hospital
ClinicalTrials.gov Identifier: NCT01031095     History of Changes
Other Study ID Numbers: BYİEAH1
Study First Received: December 11, 2009
Results First Received: January 21, 2012
Last Updated: December 24, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Bursa Postgraduate Hospital:
percutaneous coronary intervention
low dose intracoronary heparin

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 15, 2014