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Background

The SOCRATES study compares ticagrelor versus aspirin for the prevention of major vascular events in patients with acute ischemic stroke or transient ischemic attack [1,2].

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SOCRATES (Acute Stroke Or Transient IsChaemic Attack TReated with Aspirin or Ticagrelor and Patient OutcomES) is a global clinical trial involving 9,600 patients who have experienced an acute ischemic stroke or transient ischemic attack (TIA). Annually, 15 million people worldwide suffer a stroke of this type. Ischemic strokes occur as a result of an obstruction of a vessel supplying blood to the brain. A TIA is secondary to a temporary insufficient blood supply to parts of the brain and is often considered a warning sign that a stroke may follow.

SOCRATES is a randomized, parallel group study evaluating the efficacy of ticagrelor compared to aspirin in reducing major vascular events (composite of all-cause mortality, myocardial infarction [MI], and stroke) in patients with acute ischemic stroke (NIHSS ≤ 5) and TIA.

Also announced today is the initiation of THEMIS (Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study), a global clinical trial involving 17,000 patients with Type 2 diabetes at high risk of cardiovascular (CV) events. Of the 340 million people who suffer from the disease, 90 percent have type 2 diabetes and 50 percent of whom die from CV disease.

“A major goal of treating patients with diabetes is to reduce their cardiovascular risk,” said THEMIS study co-chair Deepak L. Bhatt, MD, MPH, Professor of Medicine at Harvard Medical School and Senior Physician at Brigham and Women’s Hospital.

“THEMIS will allow us to test a bold new strategy in the care of patients with diabetes who are at high risk of myocardial infarction, stroke, and cardiovascular death,” stated THEMIS study co-chair Ph. Gabriel Steg, MD, Professor of Medicine at Université Paris-Diderot and Director of the Coronary Care Unit at Hôpital Bichat.

THEMIS is an event-driven, randomized, parallel group study evaluating the efficacy of long-term treatment with ticagrelor versus placebo for the prevention of major CV events – the composite of CV death, MI or stroke – in patients with Type 2 diabetes without a history of previous MI or stroke but with documented coronary atherosclerosis.

SOCRATES and THEMIS will be monitored by Independent Data Monitoring Committees who will review the safety and efficacy of treatments in these trials. The trials will be conducted in accordance with Good Clinical Practice. Both studies will be posted on clinicaltrials.gov in the near future.

AstraZeneca is currently collaborating with over 4,000 clinical investigators in more than 30 countries as part of the PARTHENON program, and has established partnerships with a number of pre-eminent research institutions. Other studies in the PARTHENON program include PEGASUS, studying BRILINTA for secondary prevention in patients with previous myocardial infarction, and EUCLID studying patients with Peripheral Artery Disease.

PARTHENON will provide an unparalleled dataset to build scientific understanding of BRILINTA in a broad a range of atherothrombotic conditions. AstraZeneca has approved more than 100 investigator sponsored studies, which will be starting during the coming year.

BRILINTA is currently not approved for the treatment of patients with ischemic stroke, TIA, peripheral artery disease, or for secondary prevention in patients with a history of previous myocardial infarction.

BRILINTA Indications

BRILINTA is indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with ACS (unstable angina [UA], non–ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). In PLATO, BRILINTA has been shown to reduce the rate of a combined end point of CV death, myocardial infarction (MI), or stroke compared to clopidogrel. In PLATO, the difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with an artery-opening procedure known as percutaneous coronary intervention (PCI), BRILINTA reduces the rate of stent thrombosis.

BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin above 100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin above 100 mg daily.

References

1.Giacalone G, Abbas MA, Corea F. Prevention strategies for cardioembolic stroke: present and future perspectives. Open Neurol J. 2010; 4:56-63. doi: 10.2174/1874205X01004020056.

2.Silvestrelli G, Corea F, Micheli S, Lanari A. Clinical pharmacology and vascular risk.Open Neurol J. 2010;4:64-72. doi: 10.2174/1874205X01004020064.

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Starting on 29 May 2013 with many Oral Sessions fresh updates on Stroke Large clinical trials (RCTs)
at 11:25-12:30 Room: Auditorium INTERACT2, STICH II, CHIMES, IST-3, SPS3, next day PC-Trial, RESPECT, ALIAS, PHANTOM-S, ICSS, EVA-3S, STICH II.
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May anti depressants be helpfull in stroke recovery ? also in non depressed subjects ?

Double blind placebo controlled on benefit of prolonged release Levomilnacipran in ischemic stroke recovery. A phase II RCT sponsored by Pierre Fabre Medicament IRPF. First patient enrolled in France. Up to 90 participating centres, six Italian centres will join the project. Stay tuned.

How can we monitor Dabigatran effects ?

Dabigatran, like argatroban, does prolong the prothrombin time (PT) and partial thromboplastin time (PTT). It also prolongs the thrombin time (TT), which means it  generates a false decrease in fibrinogen assay results, given that the fibrinogen assay is based on the TT. Dabigatran’s plasma concentration peaks about two hours after the drug is taken, and its half-life is 12 to 17 hours, so the PT, PTT, and fibrinogen assays should be made at least 24 hours after discontinuing dabigatran. Biophen’s Hemoclot Thrombin Inhibitor allows exploration of all the direct anti-thrombin inhibitors (DTI), targeted to human thrombin.

The FDA is adding the following revisions and recommendations to the drug’s label: Healthcare professionals should prescribe the drug only to patients who can be converted into normal sinus rhythm, and the drug should be discontinued in patients in AF. Healthcare professionals should monitor the heart rhythm of patients taking dronedarone by ECG at least once every three months.
dronedarone

 

 

 

 

According to non official sources the national health care authorities in the last week abolished the formal need of triple form transcription in order to prescribe Clopidogrel for secondary prevention in non cardioembolic stroke. The need of a specialist to prescribe the drug with a so called “piano terapeutico” forced patients and stroke doctors to extra useless work.

The beneficial effect of intravenous thrombolytic therapy in patients with acute ischemic stroke attributable to internal carotid artery (ICA) occlusion remains unclear. A multicentric study gave new data on this topic. According to Italian investigators: in patients with stroke attributable to ICA occlusion, thrombolytic therapy,  results in a significant reduction in the proportion of patients dependent in activities of daily living. Increases in death and any intracranial bleeding were the trade-offs for this clinical benefit.

CNS Drugs etanercept and clinical applications

Onset of clinical response was evident within 10 minutes of perispinal injection in all patients. Improvements in hemiparesis, gait, hand function, hemi-sensory deficits, spatial perception, speech, cognition and behaviour were noted among the patients treated.

From Louisiana a new survey on dabigatran published on circulation in january : Dabigatran is a reasonable alternative to warfarin in patients requiring cardioversion.

The Italian guidelines for stroke SPREAD (sponsored by Bayer health care) reported dabigatran as a safe alternative to warfarin. This is a sort of vital validation for the molecule since almost nothing can be done in stroke medicine without the  SPREAD committee approval at a national level. At a national level also the Mario Negri istitute for pharmacology gave its valuable opinion on Pradaxa.

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