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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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014020213698N1
Enrollment
80
Registered
2014-02-02
Start date
2014-01-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: ischemic stroke. Condition 2: persistent atrial fibrillation. Condition 3: chronic atrial fibrillation. Condition 4: paroxysmal atrial fibtillation. 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 fibrill

Interventions

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
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
Active Comparator: unfractionated heparin (alborz darou,Tehran) This group will receive continuous intravenous unfractionated heparin sodium infusion 1000 unit per hour initially and

Sponsors

Shiraz University of Medical Scienses
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfshin Borhani-Haghighi

Shiraz University of Medical Sciences

borhanihaghighi@sums.ac.ir ,neuroab@gmail.com+98 71 1612 1000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026