Management Of Stroke With Piracetam 83y4
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- Pages: 33
a
c c
PLAN
r r r r r
c c
c r A stroke is "neurological deficit of cerebrovascular cause that persists beyond 24 hours or is interrupted by death within 24 hours".(WHO,1978)
c r r
WORLDWIDE:Ischemic stroke is the 2nd cause of mortality -100 to 200 new cases / 100000 inhabitants occur each year. (Feigin, Ñ
r
Developed countries: Cerebral stroke remains the third leading cause of death and the first leading cause of long-term disability in survivors. (LEYS D,1998).
r
Africa: 10% global stroke mortality (Connor , Ñ ) and 56 to 83% of these stroke patients die precociously.(SeneDiouf, 2008;Sokrab, 2002).
c !": њimportant public health problem ; epidemiologic transition ј communicable diseases ( hypertension and diabetes) which are both important risk factors for the development of stroke.
c m ama ma
Ñ
c r a a V V V
V
V V !"##$
c r Depend on the type of stroke: ѐ m : Atherosclerosis ѐ : Fat, Air, Cancer Cells, Bacteria. ѐ : Secondary to a cardiopathy ѐ : Cerebral venous sinus thrombosis due to locally increased venous pressure. ѐ : commonly due to hypertension, trauma, bleeding disorders, and vascular malformations.
c r Systemic events Cerebral Hypoperfusionї Hypoxia ї Ischaemia ї Infarction
Cerebral events Ischaemic cascade ї Cerebral oedema
! !
J Ñ
ÑÑÑ
#!"$%&&&
c r '
* CLINICAL BASED ON NEUROLOGIC EXAMINATION. Neurologic deficit and Cognitive disorder
*PARACLINCAL TESTS : CT scans, MRI scans, Doppler ultrasound, and Arteriography to determine type and subtype while blood tests together with the imaging techniques help determine cause.
c r * Occurs at stroke or neurologic Unit * Maintenance of body homeostasis is primordial . * Rehabilitative care after intensive care to regain normal life. * Prevention of modifiable risk factors
Disability : 75% of stroke survivors ѝemployability, affecting patients physically, mentally, emotionally, or a combination of the three.
c r % Drugs: ()#)" and )$*+ )!# ,)". There is still no treatment of proven efficacy and wide applicability for the acute phase of the disease; and various strategies are currently being considered, both from the point of
view
of
circulatory
impairment
(antithrombotics,
thrombolytics, etc) and from the point of view of neuroprotection of the ischaemic brain (NMDA blocking agents, sodium channel blockers, etc) -!##! %&&./
c r Piracetam is a cyclic derivative of GABA belonging to the racetams. Its chemical name is 2-oxo-1-pyrrolidine acetamide and is a nootropic drug with neuroprotective properties. History1964:Piracetam was first created in Belgium by UCB Early 1970s :approved in Europe after several clinical trials Currently it sold in over 100 countries outside the US for treating several health conditions (dementia, dyslexia, stroke, vertigo, and sickle-cell anemia )under the name Nootropil. In the US it is sold as a dietary supplement.
c r 'MECHANISM OF ACTION Exact mechanism of action unknown, & different effects have been described:
| :Restorationof neurotransmission,
improvement of metabolism which is evident in the presence of hypoxia (Giurgea 1970; Schaffler 1988)
V
:Improvement of microcirculation, decrease of platelet aggregation.(Herrschaft 1978;Moriau 1993).
'MECHANISM OF ACTION
#!"$%&&&
c ' * "))!:Injectable. Ampoule of 5 ml contains 1 g Piracetam (200 mg/ml). Film-coated tablets of400 mg .
* ",:3 - 12 grams daily . * O O O O O
)!!#)! Severe Renal Impairment Hepatic Impairment And Age <16 Years. Cerebral Hemorrhage hypersensitivity to piracetam, other pyrrolidone derivatives or any of the excipients. O First trimester for pregnant women
c r 'EFFECTS ! * Ameliorate cognitive function;language inaphasic stroke patients (Greener 2001) * The drug has been reconsidered for acute stroke treatment as well (Noble 1996).
Are few, usually mild and transient but usually well tolerated? Symptoms of general excitability (anxiety, insomnia, irritability, headache, agitation, nervousness and tremor) are occasional reported (Hakkrainen, 1978).
c Cerebral stroke is a grave condition (third leading cause of death in developed countries, and the first leading cause of long-term disability in survivors) necessitating not only an emergency treatment to prevent neurologic complications and death but a continuation therapy to halt and revert the consequences of the brain damage. Piracetam has been a molecule used for this purpose owning to its purported neuroprotective effect but its effectiveness has not been proven. A number of randomized controlled trials have preformed but none has provided conclusive evidence of the effect of piracetam for acute stroke patients thus recommending further large scale or multicenter trials for the extensive testing of the effectiveness (!##!, 2009).
c Despite its uncertain effectiveness, benefits and high cost for the patient, it is routinely and indiscriminately prescribed by practitioners in many developing countries Cameroon and Burkina Faso inclusive .It is on this grounds that we intend to carry out our multicenter randomized controlled trial to ascertain the effectiveness so as to provide a more rational treatment for the cerebral stroke. V
%
l To assess the Effectiveness and the Safety of piracetam in acute stroke patients itted in the two university teaching hospitals of Burkina Faso and Cameroon, in Sub-Saharan Africa, during a period of two years, from January 2010 to December 2011.
% c )!!()!)"0!)$#*+") '
The short term effectiveness of piracetam(Onset to 1 month)
The safety of piracetam particularly for patients with hemorrhagic stroke
Early benefits of piracetam (post stroke recuperation of neurologic function).
è r
Multicenter randomized triple-blind clinical trial comparing piracetam and placebo in the treatment of acute cerebral stroke.
Two Stroke Units in the Capital cities of Cameroon and Burkina Faso: r
University hospitals Yalgado Ouedraogo at Ouagadougou in Burkina Faso
r
University hospital of Yaoundé, in Cameroon
r
January 2010 to December 2011
è - /' r
All adult patients with CT scan confirmed stroke reporting at the Ouagadougou and Yaoundé Stroke Units within 24-48H after the onset of cerebral stroke necessitating medical treatment only.
Ø Cerebral stroke >48 H after onset of symptoms related to the current episode. Ø Past medical history of episode of stroke Ø Cerebrovascular accident associated to other co-morbidities Ø Patients with untestable GCS Ø Wish not to the study
è r
r
The two principal investigators will independently select and randomize participants at the trial centers using a random sequence of allocation generated using computer software based on tables of random digits.
r
Allocation rule defined at the start of study and respected throughout the study
p
Two groups of patients: Treatment group will receive piracetam, intravenously (800 mg of piracetam two times per day) and, orally as soon as possible (the same dosage) Control group will receive the placebo following same protocol as for treatment group. The blinding will be triple for the clinicians ,the patients and the statisticians
è r r
Assume ɲ= A (probability to be wrong)
r
and a statistical power (1-ɴ )= r& ;
r
a one month stroke mortality rate of of †† (Rosman,1986) ;
r
Previous studies claim a reduction in mortality of piracetam to 20%
r
STATCAL calculations n = Total (2 centers):500 (250 cases for same controls).
r
Succintly: Center 1 (Yaounde): )+%A&"*1#)"2""3%A4%A#)+" Center 2 (Ouagadougou): )+%A&"*1#)"2""3%A4%A#)+"
r
All the patients meeting the criteria of inclusion who give formal consent will be included
r
Assumptions:20% loss to follow-up; total patient compliance
A r
Our main outcomes of interest will be death from all causes and poor outcome (that is, dead, neurologic deficit) at the end of the acute phase (one month).
r
*First 72H: Mortality from any cause within the first 72H following start of treatment.
r
*One week-end 4 weeks: Mortality rate and Functional status using the WFNS Score
- r World Federation of Neurologic Surgeons (WFNS) Score, which was first reported in 1988 and is based on the GCS (which is in worldwide used by both nurses and physicians). r WFNS Score: I-V;
score= I representing a neurologically normal individual, and score of V representing a severely damaged/moribund patient.
A ? ?
c c
c
4=Spontaneous 3=To speech 2=To pain 1=None
5=Oriented 4=Confused 3=Inappropriate Words 2=Incomprensible
6=Obeys 5=Localizes 4=Withdraws 3=Abnormal Flexion (decortications) 2=Extension (decelerations) 1=None
1=None 99=Untestable
m
a a
?
a ?
%
%
V %
&"
' () %
' () %
*+V,-+
?
The collection of the data will envisage avoiding or minimizing any bias. Other concerns will be related to the summary of the characteristics of the treatment group and the control group, the specification of the primary and the secondary data analyses for the physicians and the nurses involved in the study, any subgroup analyses, the selection of the analytic methods, the decision about how to handle missing data in the analysis, how to interpret the results for ͞their importance͟
[ r
Permission from the Committee of Ethics of the Ministry of Health
r
Formal consent from the participants or their close relative sought for their participation to the study.
r
The Respect of their confidentiality as well as the warranty of their anonymity during the data collection and analysis proceeding, and also at the publications of the results of the study.
r
The trial management is a relevant issue and will envisage in this study : * Strick monitoring and the follow- up of the patients involved , * The measurements of the outcomes, * The handling of the loss to follow up, * Check for adverse effects * as well as the respect of patients͛ privacy.
SUMMARIZE r PROBLEM/PATIENTS: Effectiveness of Piracetam/ Cerebral Stroke patients
r INTERVENTION:Treatment with Piracetam r COMPARISON:Placebo
r OUTCOME:Death,Neurologic Deficit
r STUDY:Multicenter Triple-Blinded Randomized Clinical Trial
r THANK YOU FOR YOUR KIND ATTENTION
c c
PLAN
r r r r r
c c
c r A stroke is "neurological deficit of cerebrovascular cause that persists beyond 24 hours or is interrupted by death within 24 hours".(WHO,1978)
c r r
WORLDWIDE:Ischemic stroke is the 2nd cause of mortality -100 to 200 new cases / 100000 inhabitants occur each year. (Feigin, Ñ
r
Developed countries: Cerebral stroke remains the third leading cause of death and the first leading cause of long-term disability in survivors. (LEYS D,1998).
r
Africa: 10% global stroke mortality (Connor , Ñ ) and 56 to 83% of these stroke patients die precociously.(SeneDiouf, 2008;Sokrab, 2002).
c !": њimportant public health problem ; epidemiologic transition ј communicable diseases ( hypertension and diabetes) which are both important risk factors for the development of stroke.
c m ama ma
Ñ
c r a a V V V
V
V V !"##$
c r Depend on the type of stroke: ѐ m : Atherosclerosis ѐ : Fat, Air, Cancer Cells, Bacteria. ѐ : Secondary to a cardiopathy ѐ : Cerebral venous sinus thrombosis due to locally increased venous pressure. ѐ : commonly due to hypertension, trauma, bleeding disorders, and vascular malformations.
c r Systemic events Cerebral Hypoperfusionї Hypoxia ї Ischaemia ї Infarction
Cerebral events Ischaemic cascade ї Cerebral oedema
! !
J Ñ
ÑÑÑ
#!"$%&&&
c r '
* CLINICAL BASED ON NEUROLOGIC EXAMINATION. Neurologic deficit and Cognitive disorder
*PARACLINCAL TESTS : CT scans, MRI scans, Doppler ultrasound, and Arteriography to determine type and subtype while blood tests together with the imaging techniques help determine cause.
c r * Occurs at stroke or neurologic Unit * Maintenance of body homeostasis is primordial . * Rehabilitative care after intensive care to regain normal life. * Prevention of modifiable risk factors
Disability : 75% of stroke survivors ѝemployability, affecting patients physically, mentally, emotionally, or a combination of the three.
c r % Drugs: ()#)" and )$*+ )!# ,)". There is still no treatment of proven efficacy and wide applicability for the acute phase of the disease; and various strategies are currently being considered, both from the point of
view
of
circulatory
impairment
(antithrombotics,
thrombolytics, etc) and from the point of view of neuroprotection of the ischaemic brain (NMDA blocking agents, sodium channel blockers, etc) -!##! %&&./
c r Piracetam is a cyclic derivative of GABA belonging to the racetams. Its chemical name is 2-oxo-1-pyrrolidine acetamide and is a nootropic drug with neuroprotective properties. History1964:Piracetam was first created in Belgium by UCB Early 1970s :approved in Europe after several clinical trials Currently it sold in over 100 countries outside the US for treating several health conditions (dementia, dyslexia, stroke, vertigo, and sickle-cell anemia )under the name Nootropil. In the US it is sold as a dietary supplement.
c r 'MECHANISM OF ACTION Exact mechanism of action unknown, & different effects have been described:
| :Restorationof neurotransmission,
improvement of metabolism which is evident in the presence of hypoxia (Giurgea 1970; Schaffler 1988)
V
:Improvement of microcirculation, decrease of platelet aggregation.(Herrschaft 1978;Moriau 1993).
'MECHANISM OF ACTION
#!"$%&&&
c ' * "))!:Injectable. Ampoule of 5 ml contains 1 g Piracetam (200 mg/ml). Film-coated tablets of400 mg .
* ",:3 - 12 grams daily . * O O O O O
)!!#)! Severe Renal Impairment Hepatic Impairment And Age <16 Years. Cerebral Hemorrhage hypersensitivity to piracetam, other pyrrolidone derivatives or any of the excipients. O First trimester for pregnant women
c r 'EFFECTS ! * Ameliorate cognitive function;language inaphasic stroke patients (Greener 2001) * The drug has been reconsidered for acute stroke treatment as well (Noble 1996).
Are few, usually mild and transient but usually well tolerated? Symptoms of general excitability (anxiety, insomnia, irritability, headache, agitation, nervousness and tremor) are occasional reported (Hakkrainen, 1978).
c Cerebral stroke is a grave condition (third leading cause of death in developed countries, and the first leading cause of long-term disability in survivors) necessitating not only an emergency treatment to prevent neurologic complications and death but a continuation therapy to halt and revert the consequences of the brain damage. Piracetam has been a molecule used for this purpose owning to its purported neuroprotective effect but its effectiveness has not been proven. A number of randomized controlled trials have preformed but none has provided conclusive evidence of the effect of piracetam for acute stroke patients thus recommending further large scale or multicenter trials for the extensive testing of the effectiveness (!##!, 2009).
c Despite its uncertain effectiveness, benefits and high cost for the patient, it is routinely and indiscriminately prescribed by practitioners in many developing countries Cameroon and Burkina Faso inclusive .It is on this grounds that we intend to carry out our multicenter randomized controlled trial to ascertain the effectiveness so as to provide a more rational treatment for the cerebral stroke. V
%
l To assess the Effectiveness and the Safety of piracetam in acute stroke patients itted in the two university teaching hospitals of Burkina Faso and Cameroon, in Sub-Saharan Africa, during a period of two years, from January 2010 to December 2011.
% c )!!()!)"0!)$#*+") '
The short term effectiveness of piracetam(Onset to 1 month)
The safety of piracetam particularly for patients with hemorrhagic stroke
Early benefits of piracetam (post stroke recuperation of neurologic function).
è r
Multicenter randomized triple-blind clinical trial comparing piracetam and placebo in the treatment of acute cerebral stroke.
Two Stroke Units in the Capital cities of Cameroon and Burkina Faso: r
University hospitals Yalgado Ouedraogo at Ouagadougou in Burkina Faso
r
University hospital of Yaoundé, in Cameroon
r
January 2010 to December 2011
è - /' r
All adult patients with CT scan confirmed stroke reporting at the Ouagadougou and Yaoundé Stroke Units within 24-48H after the onset of cerebral stroke necessitating medical treatment only.
Ø Cerebral stroke >48 H after onset of symptoms related to the current episode. Ø Past medical history of episode of stroke Ø Cerebrovascular accident associated to other co-morbidities Ø Patients with untestable GCS Ø Wish not to the study
è r
r
The two principal investigators will independently select and randomize participants at the trial centers using a random sequence of allocation generated using computer software based on tables of random digits.
r
Allocation rule defined at the start of study and respected throughout the study
p
Two groups of patients: Treatment group will receive piracetam, intravenously (800 mg of piracetam two times per day) and, orally as soon as possible (the same dosage) Control group will receive the placebo following same protocol as for treatment group. The blinding will be triple for the clinicians ,the patients and the statisticians
è r r
Assume ɲ= A (probability to be wrong)
r
and a statistical power (1-ɴ )= r& ;
r
a one month stroke mortality rate of of †† (Rosman,1986) ;
r
Previous studies claim a reduction in mortality of piracetam to 20%
r
STATCAL calculations n = Total (2 centers):500 (250 cases for same controls).
r
Succintly: Center 1 (Yaounde): )+%A&"*1#)"2""3%A4%A#)+" Center 2 (Ouagadougou): )+%A&"*1#)"2""3%A4%A#)+"
r
All the patients meeting the criteria of inclusion who give formal consent will be included
r
Assumptions:20% loss to follow-up; total patient compliance
A r
Our main outcomes of interest will be death from all causes and poor outcome (that is, dead, neurologic deficit) at the end of the acute phase (one month).
r
*First 72H: Mortality from any cause within the first 72H following start of treatment.
r
*One week-end 4 weeks: Mortality rate and Functional status using the WFNS Score
- r World Federation of Neurologic Surgeons (WFNS) Score, which was first reported in 1988 and is based on the GCS (which is in worldwide used by both nurses and physicians). r WFNS Score: I-V;
score= I representing a neurologically normal individual, and score of V representing a severely damaged/moribund patient.
A ? ?
c c
c
4=Spontaneous 3=To speech 2=To pain 1=None
5=Oriented 4=Confused 3=Inappropriate Words 2=Incomprensible
6=Obeys 5=Localizes 4=Withdraws 3=Abnormal Flexion (decortications) 2=Extension (decelerations) 1=None
1=None 99=Untestable
m
a a
?
a ?
%
%
V %
&"
' () %
' () %
*+V,-+
?
The collection of the data will envisage avoiding or minimizing any bias. Other concerns will be related to the summary of the characteristics of the treatment group and the control group, the specification of the primary and the secondary data analyses for the physicians and the nurses involved in the study, any subgroup analyses, the selection of the analytic methods, the decision about how to handle missing data in the analysis, how to interpret the results for ͞their importance͟
[ r
Permission from the Committee of Ethics of the Ministry of Health
r
Formal consent from the participants or their close relative sought for their participation to the study.
r
The Respect of their confidentiality as well as the warranty of their anonymity during the data collection and analysis proceeding, and also at the publications of the results of the study.
r
The trial management is a relevant issue and will envisage in this study : * Strick monitoring and the follow- up of the patients involved , * The measurements of the outcomes, * The handling of the loss to follow up, * Check for adverse effects * as well as the respect of patients͛ privacy.
SUMMARIZE r PROBLEM/PATIENTS: Effectiveness of Piracetam/ Cerebral Stroke patients
r INTERVENTION:Treatment with Piracetam r COMPARISON:Placebo
r OUTCOME:Death,Neurologic Deficit
r STUDY:Multicenter Triple-Blinded Randomized Clinical Trial
r THANK YOU FOR YOUR KIND ATTENTION
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