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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.
Aim:
Primary objective:To evaluate the efficiency and safety of low dose intracoronary unfractioned heparin (UFH) on elective percutaneous coronary intervention (PCI).
Secondary objective:
Study central:
Study population:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose intracoronary heparin | Experimental | Low dose intracoronary heparin: In this group elective coronary intervention was performed with low dose intracoronary Heparin |
|
| Standard treatment arm | Active Comparator | Standard treatment arm: In this group elective coronary intervention performed with standard dose intravenous heparin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coronary intervention | Other | elective coronary intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events | 30 days | |
| Major Adverse Cardiac Event | 30 days |
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Inclusion Criteria:
The patients; who have planned elective PCI and have had written informed consent for participation to study.
The native coronary artery;
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hasan Arı, MD | Bursa Postgraduate Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi | Bursa | 16320 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18929239 | Background | 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. | |
| 25643432 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose Intracoronary Heparin | Low dose intracoronary heparin treatment arm |
| FG001 | Standard Therapy | standard unfractionated heparin (UFH) treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose Intracoronary Heparin | Low dose intracoronary heparin treatment arm |
| BG001 | Standard Therapy | standard UFH treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Major Adverse Cardiac Events | Posted | Number | percentage of event | 30 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose Intracoronary Heparin | Low dose intracoronary heparin treatment arm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MI | Cardiac disorders | Systematic Assessment |
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The intraprocedural use of a heparinised flush was not controlled; however, given the maximum amount that was allowed to be used, this is not likely to have significantly affected the activated clotting times. .
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Hasan ARI | Bursa Postgraduate Hospital | 00902243605050 | 1739 | hasanari03@yahoo.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Derived |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Major Adverse Cardiac Event | Posted | Number | percentage of event | 30 days |
|
|
|
| 1 |
| 100 |
| 0 |
| 100 |
| EG001 | Standard Therapy | standard UFH treatment | 2 | 100 | 0 | 100 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D019060 | Minimally Invasive Surgical Procedures |