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IRCT2014020213698N1 IRCT 2014-02-02 Shiraz University of Medical Scienses The comparison of 2 types of heparin ( unfractionated vs low molecular weight heparin) in patients with stroke due to atrial fibrillation The Study of the efficacy, safety and tolerability of low molecular weight heparin vs. unfractionated heparin in patients with embolic stroke due to atrial fibrillation 2014-01-01 anticipated 80 Complete https://irct.ir/trial/13492 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 2 Condition 1: ischemic stroke. Condition 2: persistent atrial fibrillation. Condition 3: chronic atrial fibrillation. Condition 4: paroxysmal atrial fibtillation. Intervention 1: Experimental: Low molecular-weight heparin( enoxaparin ; Clexane, Sanofi, Paris) these patients will receive 1 mg of enoxaparin (clexane) per kilogram of body weight subcutaneous every 12 hour with warfarin 5mg QD and both drugs will be continued until the target INR level (2.5) is reached then clexane will be discontinued. Intervention 2: Active Comparator: unfractionated heparin (alborz darou,Tehran) This group will receive continuous intravenous unfractionated heparin sodium infusion 1000 unit per hour initially and then the dose will be adjusted to maintain a therapeutic aPTT level (two times to baseline) then warfarin will be started (5 mg QD).
public Afshin Borhani-Haghighi
Zand Blv.
Shiraz Iran (Islamic Republic of) +98 71 1612 1000 borhanihaghighi@sums.ac.ir ,neuroab@gmail.com Shiraz University of Medical Sciences scientific Afshin Borhani-Hghighi
Motahari polyclinic, Nemazee sq.
Shiraz Iran (Islamic Republic of) +98 71 1612 1000 borhanihaghighi@sums.ac.ir ,neuroab@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion Criteria: confirmed diagnosis of acute ischemic stroke purely due to AF AF confirmed by ECG or 24 hour holter monitoring Patients who need initiation of anticoagulation for prevention of recurrent stroke /// Exclusion Criteria: ages less than 18 or more than 75 no cooperation CNS hemorrhage major bleeding infarction size of more than one third of MCA territory NIHS score more than 20 hypersensitivity to IV UFH or LMWH no informed consent other causes for stroke except AF pregnancy breast feeding uncontrolled HTN (BP more than 220/120) renal, hepatic, respiratory or cardiac failure myocardial infarction infectious endocarditis coma vasculitis dissection 18 years 75 years Both I63.9 I48 148.2 148.0 A disorder characterized by a sudden loss of sensory function due to an intracranial vascular event. A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to brain ischemia or intracranial hemorrhages Atrial fibrillation and flutter Continuous or recurrent bouts of atrial fibrillation. Sudden and episodic bouts of atrial fibrillation. Treatment - Drugs Treatment - Drugs Experimental: Low molecular-weight heparin( enoxaparin ; Clexane, Sanofi, Paris) these patients will receive 1 mg of enoxaparin (clexane) per kilogram of body weight subcutaneous every 12 hour with warfarin 5mg QD and both drugs will be continued until the target INR level (2.5) is reached then clexane will be discontinued. Active Comparator: unfractionated heparin (alborz darou,Tehran) This group will receive continuous intravenous unfractionated heparin sodium infusion 1000 unit per hour initially and then the dose will be adjusted to maintain a therapeutic aPTT level (two times to baseline) then warfarin will be started (5 mg QD). Mortality. Timepoint: 7 days and 90 days after stroke. Method of measurement: close observation in hospital and telephone interview after discharge. Ischemic stroke. Timepoint: 7 days and 90 days after stroke. Method of measurement: CT scan and daily physical examination. Hemorrhagic stroke. Timepoint: 7 days and 90 days after stroke. Method of measurement: CT scan and daily physical examination. Symptomatic CNS hemorrhage. Timepoint: 7 days and 90 days after stroke. Method of measurement: CT scan. Non-CNS hemorrhage. Timepoint: 7 days and 90 days after stroke. Method of measurement: CT scan. Asymptomatic CNS_hemorrhage. Timepoint: 7 days and 90 days after stroke. Method of measurement: CT scan. Time to reach target INR. Timepoint: average time is 7 to 10 days (it is variable between individuals). Method of measurement: laboratory. Tolerability of drugs. Timepoint: during hospital admission while the patient is receiving anticoagulant. Method of measurement: daily physical exam. Shiraz University of Medical Scienses Approved 2013-12-25 Vice chancellor for research affairs, ethics comittee Zand Aenue Shiraz Iran (Islamic Republic of)