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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 (REDUCED)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Bursa Postgraduate Hospital
ClinicalTrials.gov Identifier:
NCT01031095
First received: December 11, 2009
Last updated: December 30, 2009
Last verified: November 2008
History of Changes
  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
 Device: percutaneous coronary intervention with low dose intracoronary heparin
 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

Resource links provided by NLM:

Drug Information available for: Heparin
U.S. FDA Resources

Further study details as provided by Bursa Postgraduate Hospital:

Primary Outcome Measures:
  • Death, MI or TVR revascularization within 30 days. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Major or minor bleeding according to TIMI criteria [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: June 2009
Estimated 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 Device: percutaneous coronary intervention with low dose intracoronary heparin
low dose intracoronary heparin to target vessel (1000 IU unfractioned heparin) when performing PCI

  Show Detailed Description

  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 LMCA lesion
    • no chronic total occlusion lesion

Exclusion Criteria:

  • Patients have allergy for ASA, Clopidogrel and heparin
  • Patients who performed primary PCI
  • Patients with acute coronary syndrome
  • Patients with have a history of MI for two weeks
  • Patients who were use UFH or 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: Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi, Cardiology
ClinicalTrials.gov Identifier: NCT01031095     History of Changes
Other Study ID Numbers: BYİEAH1
Study First Received: December 11, 2009
Last Updated: December 30, 2009
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
Calcium heparin
 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 May 16, 2013