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Completed

NCT Number: NCT01031095

(A Novel Pharmacologic Regime 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.

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, 16320, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

coronary intervention

Other

elective coronary intervention

Primary outcomes

  1. Major Adverse Cardiac Events

    Time frame: 30 days

  2. Major Adverse Cardiac Event

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Bursa Postgraduate Hospital

Other

Registry information

Official study title

A RandomisED StUdy Comparing Standard Systemic Anticoagulation ThErapy to Low Dose Intracoronary Anticoagulation Therapy for Elective Percutaneous Coronary Intervention

Acronym: REDUCED

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Dec 14, 2009
Registry last updated
Jan 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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