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

• ClinicalTrials.gov Identifier: NCT01031095
• Recruitment Status: Completed
• First Posted: December 14, 2009
• Results First Posted: October 10, 2013
• Last Update Posted: January 30, 2014
• Sponsor: Bursa Postgraduate Hospital
• Information provided by (Responsible Party): Hasan ARI, Bursa Postgraduate Hospital

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Coronary Artery Disease	Other: coronary intervention	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: June 2009
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: June 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Major Adverse Cardiac Events [ Time Frame: 30 days ]
2. Major Adverse Cardiac Event [ Time Frame: 30 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ari H, Kivaç E, Ari S, Emlek N, Cetinkaya S, Celiloğlu 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.

• Responsible Party: Hasan ARI, Bursa Postgraduate Hospital
• ClinicalTrials.gov Identifier: NCT01031095
• Other Study ID Numbers: BYİEAH1
• First Posted: December 14, 2009
• Results First Posted: October 10, 2013
• Last Update Posted: January 30, 2014
• Last Verified: December 2013

Keywords provided by Hasan ARI, Bursa Postgraduate Hospital:

percutaneous coronary intervention; low dose intracoronary heparin

Additional relevant MeSH terms:

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases