Coronary Artery Disease
Conditions
Keywords
percutaneous coronary intervention, low dose intracoronary heparin
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.
Interventions
elective coronary intervention
Sponsors
Bursa Postgraduate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac Events | 30 days |
| Major Adverse Cardiac Event | 30 days |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Dose Intracoronary Heparin Low dose intracoronary heparin treatment arm | 100 |
| Standard Therapy standard UFH treatment | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Standard Therapy | Low Dose Intracoronary Heparin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants | 80 Participants | 160 Participants |
| Age, Continuous | 58.99 years STANDARD_DEVIATION 11.24 | 59.11 years STANDARD_DEVIATION 9.68 | 59.06 years STANDARD_DEVIATION 10.46 |
| Region of Enrollment Turkey | 100 participants | 100 participants | 200 participants |
| Sex: Female, Male Female | 19 Participants | 25 Participants | 44 Participants |
| Sex: Female, Male Male | 81 Participants | 75 Participants | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 1 / 100 | 2 / 100 |
Outcome results
Primary
Major Adverse Cardiac Event
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Therapy | Major Adverse Cardiac Event | 1 percentage of event |
Primary
Major Adverse Cardiac Events
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Therapy | Major Adverse Cardiac Events | 2 percentage of event |