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Study of the Efficacy, Safety and Tolerability of Low Molecular Weight Heparin vs. Unfractionated Heparin in Stroke

Information source: Shiraz University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Embolic Stroke

Intervention: Enoxaparin (Drug); Heparin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Shiraz University of Medical Sciences

Official(s) and/or principal investigator(s):
Afshin Borhani Haghighi, Associate professor, Principal Investigator, Affiliation: Shiraz University of medical sciences, department of neurology
Farnia Feiz, medical student, Study Chair, Affiliation: Shiraz University of Medical Sciences
Reyhane Sedghi, medical student, Study Chair, Affiliation: Shiraz University of Medical Sciences

Overall contact:
Afshin Borhani-Haghighi, Associate professor, Phone: 00989177029134, Email: Aborhani@sums.ac.ir

Summary

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.

Clinical Details

Official title: Study of the Efficacy, Safety and Tolerability of Low Molecular Weight Heparin vs. Unfractionated Heparin as Bridging Therapy in Patients With Embolic Stroke Due to Atrial Fibrillation

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

mortality

ischemic stroke

hemorrhagic stroke

Secondary outcome:

symptomatic CNS hemorrhage

Non-CNS hemorrhage

asymptomatic CNS_hemorrhage

time to reach target INR

tolerability of drugs

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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 middle cerebral artery territory

- National Institutes of Health Stroke Scale (NIHSS) more than 20

- hypersensitivity to IV UFH or LMWH

- no informed consent

- other causes for stroke except AF

- pregnancy

- breast feeding

- uncontrolled hypertension (BP more than 220/120)

- renal, hepatic, respiratory or cardiac failure

- myocardial infarction

- infectious endocarditis

- coma

- vasculitis

- dissection

Locations and Contacts

Afshin Borhani-Haghighi, Associate professor, Phone: 00989177029134, Email: Aborhani@sums.ac.ir

Faghihi hospital, Shiraz, Fars 7134844119, Iran, Islamic Republic of; Recruiting
Farnia Feiz, MD, Phone: 00989177383403, Email: farniafeiz@gmail.com

Nemazi hospital, Shiraz, Fars 11351-71937, Iran, Islamic Republic of; Recruiting
Reyhane Sedghi, MD, Phone: 00989177035783, Email: reihaneh.sedghi@gmail.com

Additional Information

Related publications:

Shahpouri MM, Mousavi S, Khorvash F, Mousavi SM, Hoseini T. Anticoagulant therapy for ischemic stroke: A review of literature. J Res Med Sci. 2012 Apr;17(4):396-401.

Kase CS, Albers GW, Bladin C, Fieschi C, Gabbai AA, O'Riordan W, Pineo GF; PREVAIL Investigators. Neurological outcomes in patients with ischemic stroke receiving enoxaparin or heparin for venous thromboembolism prophylaxis: subanalysis of the Prevention of VTE after Acute Ischemic Stroke with LMWH (PREVAIL) study. Stroke. 2009 Nov;40(11):3532-40. doi: 10.1161/STROKEAHA.109.555003. Epub 2009 Aug 20.

Algra A, de Schryver EL, van Gijn J, Kappelle LJ, Koudstaal PJ. Oral anticoagulants versus antiplatelet therapy for preventing further vascular events after transient ischaemic attack or minor stroke of presumed arterial origin. Cochrane Database Syst Rev. 2001;(4):CD001342. Review. Update in: Cochrane Database Syst Rev. 2006;(3):CD001342.

Saxena R, Lewis S, Berge E, Sandercock PA, Koudstaal PJ. Risk of early death and recurrent stroke and effect of heparin in 3169 patients with acute ischemic stroke and atrial fibrillation in the International Stroke Trial. Stroke. 2001 Oct;32(10):2333-7.

Hallevi H, Albright KC, Martin-Schild S, Barreto AD, Savitz SI, Escobar MA, Gonzales NR, Noser EA, Illoh K, Grotta JC. Anticoagulation after cardioembolic stroke: to bridge or not to bridge? Arch Neurol. 2008 Sep;65(9):1169-73. doi: 10.1001/archneur.65.9.noc70105. Epub 2008 Jul 14.

Guyatt GH, Akl EA, Crowther M, Gutterman DD, Schu√ľnemann HJ; American College of Chest Physicians Antithrombotic Therapy and Prevention of Thrombosis Panel. Executive summary: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):7S-47S. doi: 10.1378/chest.1412S3. Erratum in: Chest. 2012 Dec;142(6):1698. Dosage error in article text. Chest. 2012 Apr;141(4):1129. Dosage error in article text.

Fahimi F, Baniasadi S, Behzadnia N. Enoxaparin Utilization Evaluation: An Observational Prospective Study in Medical Inpatients. Iranian Journal of Pharmaceutical Research 2008;7 (1):77-82.

Kalafut MA, Gandhi R, Kidwell CS, Saver JL. Safety and cost of low-molecular-weight heparin as bridging anticoagulant therapy in subacute cerebral ischemia. Stroke. 2000 Nov;31(11):2563-8.

Adams HP Jr, del Zoppo G, Alberts MJ, Bhatt DL, Brass L, Furlan A, Grubb RL, Higashida RT, Jauch EC, Kidwell C, Lyden PD, Morgenstern LB, Qureshi AI, Rosenwasser RH, Scott PA, Wijdicks EF; American Heart Association; American Stroke Association Stroke Council; Clinical Cardiology Council; Cardiovascular Radiology and Intervention Council; Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: the American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Stroke. 2007 May;38(5):1655-711. Epub 2007 Apr 12. Erratum in: Stroke. 2007 Jun;38(6):e38. Stroke. 2007 Sep;38(9):e96.

Cohen M, Demers C, Gurfinkel EP, Turpie AG, Fromell GJ, Goodman S, Langer A, Califf RM, Fox KA, Premmereur J, Bigonzi F. A comparison of low-molecular-weight heparin with unfractionated heparin for unstable coronary artery disease. Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events Study Group. N Engl J Med. 1997 Aug 14;337(7):447-52.

Burak CR, Bowen MD, Barron TF. The use of enoxaparin in children with acute, nonhemorrhagic ischemic stroke. Pediatr Neurol. 2003 Oct;29(4):295-8.

Starting date: January 2014
Last updated: June 6, 2014

Page last updated: August 23, 2015

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