A Phase 2 interventional study of Enoxaparin and Heparin in Embolic Stroke, sponsored by Shiraz University of Medical Sciences. Status unknown at 2 sites in Iran, Islamic Republic of. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-09.
Sponsored by Shiraz University of Medical Sciences · Phase 2, Interventional, and Prevention
Patients with Atrial fibrillation (AF) make a unique group of ischemic stroke, mostly caused by emboli from the left atrial appendage. Oral anticoagulation (Warfarin) is recommended for prevention of recurrent embolic stroke but it takes several days to reach a therapeutic international normalized ratio (INR : 2.5) so bridging therapy with a short acting intravenous anticoagulant is recommended until therapeutic INR level is reached. A common strategy is to use intravenous unfractionated heparin (UFH) until a standard activated partial thromboplastin time (aPTT) is reached and then initiating warfarin. Another strategy is to use subcutaneous (SQ) injection of a low-molecular-weight heparin (LMWH) eg. Enoxaparin.
The investigators will compare LMWH and UFH, focusing on risk of new stroke and mortality rate.
METHOD: This study is randomized controlled trial that will be performed in 80 patients ages between 18 and 75 with confirmed acute ischemic stroke purely due to AF who will be hospitalized in Shiraz Medical University affiliated teaching hospitals. Patients will be randomly assigned in two groups. A brain CT will be done to confirm the absence of intracranial hemorrhage and to assess the size of cerebral ischemia.
First group will receive 1 mg of enoxaparin (Clexane, Sanofi, Paris) per kilogram of body weight SQ every 12 hour with warfarin 5mg orally everyday and both drugs will be continued until the target INR level (2.5) is reached then clexane will be discontinued.
The second group will receive continuous UFH infusion 1000 unit per hour and then the dose will be adjusted to maintain a therapeutic aPTT (two times to baseline) level then warfarin will be started (5 mg everyday).
The investigators will follow patients in both groups until target INR will be achieved (2.5) and after that clexane and UFH will be discontinued. Adverse events will be assessed in both groups for three months.
Data will be analyzed with Statistical Package for the Social Sciences (SPSS) version 15 and Chi-square statistics.
Main outcome of our study will be evaluation of new stroke, mortality, central nervous system (CNS) hemorrhage, major bleeding, drop out and other unwanted side effects in first week and three months after stroke.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Shiraz University of Medical Sciences is the lead sponsor of 129 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Enoxaparin
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).
Drug: Heparin
1 mg of enoxaparin per kilogram of body weight subcutaneous every 12 hour
Also known as: clexane (Clexane, Sanofi, Paris)
1000 unit per hour continuous intravenous infusion of heparin sodium
Also known as: Heparin Sodium (Alborz Darou,Tehran)
mortality
all death cases are included but only mortality due to cerebrovascular accident are considered.
Time frame: up to the 3 months of follow-up
ischemic stroke
Ischemic strokes are those that are caused by interruption of the blood supply
Time frame: up to the 3 months of follow-up
hemorrhagic stroke
hemorrhagic strokes are the ones which result from rupture of a blood vessel or an abnormal vascular structure.
Time frame: up to the 3 months of follow-up
symptomatic CNS hemorrhage
Intracranial bleeding occurs when a blood vessel within the skull is ruptured or leaks that causes neurological symptoms. It can result from nontraumatic causes as occurs in hemorrhagic stroke such as a ruptured aneurysm. Anticoagulant therapy can heighten the risk that an intracranial hemorrhage will occur.
Time frame: up to the 3 months of follow-up
Non-CNS hemorrhage
any bleeding of other sites of body except CNS.
Time frame: up to the 3 months of follow-up
asymptomatic CNS_hemorrhage
Intracranial bleeding occurs when a blood vessel within the skull is ruptured or leaks that will not cause neurological symptoms. It can result from nontraumatic causes as occurs in hemorrhagic stroke such as a ruptured aneurysm. Anticoagulant therapy can heighten the risk that an intracranial hemorrhage will occur.
Time frame: up to the 3 months of follow-up
time to reach target INR
the therapeutic INR level for patients on warfarin therapy is between 2.0 to 3.0.
Time frame: average time 7 to 10 days (it is variable between individuals)
tolerability of drugs
tolerability is how a patient can tolerate heparin and LMWH in terms of side effect and route of administration.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Shiraz University of Medical Sciences