(A Novel Pharmacologic Regime for Elective Percutaneous Coronary

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01031095
Study type	Interventional
Source	Bursa Postgraduate Hospital
Contact
Status	Completed
Phase	Phase 3
Start date	June 2009
Completion date	June 2010

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention) — REDUCED

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms