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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16320
    • Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major Adverse Cardiac Events	30 days
Major Adverse Cardiac Event	30 days

Collaborators and Investigators

• Sponsor: Bursa Postgraduate Hospital
• Investigators: Study Director: Hasan Arı, MD, Bursa Postgraduate Hospital

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.jacc.2008.07.026.
• Ari H, Kivac E, Ari S, Emlek N, Cetinkaya S, Celiloglu N, Sarigul OY, Aydin C, Akkaya M, Koca V, Bozat T, Gurdogan M. The REDUCED (a RandomisED stUdy Comparing standard systemic anticoagulation thErapy to low Dose intracoronary anticoagulation therapy for elective percutaneous coronary intervention) trial. A novel pharmacologic regime for elective percutaneous coronary intervention. Acta Cardiol. 2014 Dec;69(6):619-27. doi: 10.1080/ac.69.6.1000004.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: December 11, 2009
• First Submitted That Met QC Criteria: December 11, 2009
• First Posted (Estimate): December 14, 2009

Study Record Updates

• Last Update Posted (Estimate): January 30, 2014
• Last Update Submitted That Met QC Criteria: December 24, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; low dose intracoronary heparin
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: BYİEAH1