(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention)

Coronary Artery Disease Clinical Trial

— REDUCED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031095
• Other study ID #: BYIEAH1
• Status: Completed
• Phase: Phase 3
• First received: December 11, 2009
• Last updated: December 24, 2013
• Start date: June 2009
• Est. completion date: June 2010

Study information

• Verified date: December 2013
• Source: Bursa Postgraduate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• coronary intervention
elective coronary intervention

Locations

Country	Name	City	State
Turkey	Bursa Yüksek Ihtisas Egitim ve Arastirma Hastanesi	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Postgraduate Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events		30 days	Yes
Primary	Major Adverse Cardiac Event		30 days	Yes