(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention)

NCT ID: NCT01031095

Last Updated: 2014-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-06-30

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low dose intracoronary heparin

Low dose intracoronary heparin: In this group elective coronary intervention was performed with low dose intracoronary Heparin

Group Type: EXPERIMENTAL

coronary intervention

Intervention Type: OTHER

elective coronary intervention

Standard treatment arm

Standard treatment arm: In this group elective coronary intervention performed with standard dose intravenous heparin

Group Type: ACTIVE_COMPARATOR

coronary intervention

Intervention Type: OTHER

elective coronary intervention

Interventions

coronary intervention

elective coronary intervention

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bursa Postgraduate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hasan ARI

Bursa Postgraduate Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hasan Arı, MD

Role: STUDY_DIRECTOR

Bursa Postgraduate Hospital

Locations

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 18929239 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25643432 (View on PubMed)

Other Identifiers

BYİEAH1

Identifier Type: -

Identifier Source: org_study_id