Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-28 @ 2:22 PM
Study NCT ID:
NCT01031095
Status:
COMPLETED
Last Update Posted:
2014-01-30
First Post:
2009-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention)
Sponsor:
Bursa Postgraduate Hospital
Organization:
Study Overview
Official Title:
A RandomisED StUdy Comparing Standard Systemic Anticoagulation ThErapy to Low Dose Intracoronary Anticoagulation Therapy for Elective Percutaneous Coronary Intervention
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REDUCED
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: