Clinical trial NCT01031095: (A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention)
Official title: A RandomisED StUdy Comparing Standard Systemic Anticoagulation ThErapy to Low Dose Intracoronary Anticoagulation Therapy for Elective Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: percutaneous coronary intervention
low dose intracoronary heparin
Lead sponsor: Bursa Postgraduate Hospital
Sponsor class: OTHER
First posted: 2009-12-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Major Adverse Cardiac Events
timeFrame: 30 days
measure: Major Adverse Cardiac Event
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Study officials:
affiliation: Bursa Postgraduate Hospital
name: Hasan Arı, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.