Aktuelle Schlaganfallstudien

TICH-NOAK (Treatment of intracerebral hemorrhage in patients on non-vitamin K oral anticoagulants with tranexamic acid)

PI Georg Kägi

Einschlusskriterien:

  • Acute intracerebral haemorrhage
  • Prior treatment with a non-vitamin K antagonist oral anticoagulant (NOAC: apixaban, dabigatran, edoxaban or rivaroxaban; last intake <48hours OR proven* NOAC activity by relevant coagulation assays) )
  • Time of onset <12 hours (or in patients with unknown time of symptom onset, the time patient was last known to be well divided by 2)
  • Age >18 years, No upper age limit
  • Informed consent

*proven NOAC activity is defined as measurable NOAC plasma levels with a suitable specific coagulation test (calibrated anti-factor Xa activity, escarin clotting time) if available

Ausschlusskriterien:

  • Severe pre-morbid disability (modified Rankin scale >4)
  • Anticoagulation with VKA
  • Secondary intracerebral hemorrhage (e.g., AVM, tumor) Note it is not necessary for investigators to exclude underlying structural abnormality prior to enrolment, but where an underlying structural abnormality is already known, these patients should not be recruited.
  • Glasgow coma scale <5
  • pregnancy
  • Planned neurosurgical hematoma evacuation within 24 hours (before follow-up imaging)
  • Recent pulmonary embolism/deep vein thrombosis within the last 2 weeks

 

TREAT-CAD (Biomarkers and antithrombotic treatment in cervical artery dissection (TREAT-CAD))

PI Georg Kägi

Einschlusskriterien:

  • Acute ischemic or non-ischemic symptoms within 2 weeks
  • Verification of CAD-diagnosis (carotid and/or vertebral) by MR-techniques (at least one):
    • mural hematoma or
    • pseudo-aneurysm or
    • long filiform stenosis or
    • intimal flap or
    • double lumen or
    • occlusion situated more than 2 cm above the bifurcation of the carotid artery, revealing a pseudo aneurysm or a long filiform stenosis after recanalisation.
  • Written informed consent by patient or next-to-kin
  • 24h latency period in case of thrombolysis
  • Age > 18 years by time of inclusion

Ausschlusskriterien:

  • MR-contraindications (claustrophobia precluding MRI: patients agreeing to undergo MRI scanning with mild sedation may be entered into the study)
  • Contraindications to the use of anticoagulation (vitamin k antagonists, heparin) or ASA (according to the Swiss “Arzneimittelkompendium” http://www.compendium.ch/search/de or the “Rote Liste” (German centers) or
  • and the judgment of the treating physician)
  • Pregnancy (Note: for women in child bearing age a pregnancy test has to be done prior to study entry)

 

ELAN (Early versus Late initiation of direct oral Anticoagulants in post-ischaemic stroke patients with atrial fibrillatioN (ELAN): an international, multicentre, randomised-controlled, two-arm, assessor-blinded trial)

PI Jochen Vehoff

Einschlusskriterien:

  • Written informed consent
  • Age: ≥8 years
  • Acute ischaemic stroke, either confirmed by MRI or CT scan (tissue based definition) or by sudden focal neurological deficit of presumed ischaemic origin that persisted beyond 24 hours and otherwise normal non-contrast CT scan. Please note: prior intravenous or endovascular treatment is allowed.
  • Permanent, persistent, or paroxysmal spontaneous AF previously known or diagnosed during the index hospitalization
  • Agreement of treating physician to prescribe DOACs

Ausschlusskriterien:

  • Atrial fibrillation due to reversible causes (e.g. thyrotoxicosis, pericarditis, recent surgery, myocardial infarct)19
  • Valvular disease requiring surgery
  • Mechanical heart valve(s)
  • Moderate or severe mitral stenosis. Please note that other valvular diseases and biological valves are eligible
  • AF and conditions other than AF that require anticoagulation, including therapeutical dose of low-molecular-weight heparin or heparin. Please note: infratherapeutic anticoagulation at ischaemic stroke onset defined as follows is not an exclusion criteria:
    • Vitamine K antagonist: International Normalized Ratio (INR) < 1.7
    • Anti-IIa: thrombin time < 80 seconds and/or anti-IIa < 50 ng/ml
    • Anti-Xa: anti-Xa < 50 ng/ml
  • Subject who is contraindicated to DOACs
  • Female who is pregnant or lactating or has a positive pregnancy test at time of admission
  • Patients with serious bleeding in the last 6 months or at high risk of bleeding (e.g. active peptic ulcer disease, platelet count < 100’000/mm3 or haemoglobin < 10 g/dl or INR ≥1.7, documented haemorrhagic tendencies or blood dyscrasias)
  • Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day)
  • Severe comorbid condition with life expectancy < 6 months
  • Severe or moderate renal insufficiency as defined by creatinine clearance < 50 ml/min
  • Subject who requires haemodialysis or peritoneal dialysis
  • Subject with aortic dissection
  • Current participation in another investigational trial
  • Dual antiplatelet therapy at baseline or strong likelihood to be treated with dual antiplatelet therapy during the course of the trial
  • CT or MRI evidence of haemorrhage classified as PH1 (defined as parenchymal haemorrhage = blood clots in < 30% of the infarcted area without or with slight space-occupying effect) and PH2 (defined as blood clots in > 30% of the infarcted area with a substantial space-occupying effect)42 independently of clinical deterioration. Please note that HI1 (defined as haemorrhagic infarct = small petechiae along the margins of the infarct) and HI2 (defined as confluent petechiae within the infarcted area but no space occupying effect)42 are acceptable if not associated with clinical deterioration and if the treating physician feels comfortable to treat patients with DOACs.
  • CT or MRI evidence of mass effect or intra-cranial tumour (except small meningioma)
  • CT or MRI evidence of cerebral vasculitis
  • Endocarditis
  • Evidence of severe cerebral amyloid angiopathy if MRI scan performed

 

eSATIS (Early Sleep Apnea Treatment in Stroke: A Multi-center, Randomized, Rater-Blinded, Clinical Trial of Adaptive Servo-Ventilation)

PI  Dominique Flügel

Einschlusskriterien:

  • Informed consent
  • Admission to one of the participating center
  • Age 18-85 years
  • Ischemic stroke detectable by neuroimaging, affecting internal carotid artery, anterior cerebral artery (ACA), middle cerebral artery (MCA), posterior cerebral artery (PCA) and/or branches thereof
  • Symptom onset to admission < 24h
  • AHI > 20 / h or < 5 / h

Ausschlusskriterien:

  • Primary hemorrhagic stroke
  • Secondary parenchymal hemorrhage (PH 1 and PH 2 according to ECASS) (secondary haem-orrhagic infarction HI 1 and HI 2 can be included)
  • Coma/stupor
  • Small strokes (diameter <1.5 cm)
  • Intubation
  • Clinically unstable or life threatening condition (oxygen-dependent pulmonary disease or severe pulmonary complications, severe renal or liver insufficiency, agitated patient, patients under blood pressure-elevating substances >24h after stroke, patients that need decompressive car-niectomy)
  • Heart failure defined as known congestive heart failure (CHF) functional class NYHA III-IV (New York Heart Association) OR CHF NYHA II and hospitalization caused by CHF in the preceding 24 months OR left ventricular ejection fraction lower or equal than 45% either known from pre-ceding imaging method or found at the routine examination (echocardiography) during hospitali-zation
  • Oxygen supply > 2 l/min during day and night.
  • Intermediate AHI value: ≥ 5/h and ≤ 20/h
  • Known progressive neurological diseases (such as dementia, Parkinson’s disease or multiple sclerosis)
  • Drug or alcohol abuse (>14 units alcohol / week for males, >7 units alcohol / week for females)
  • Inability to follow study procedure
  • Pregnancy
  • Any given contraindications to MRI or MRI-contrast (allergy or severe renal impairment):
    • various non-MR-compatible ferrous or metallic implants or medical devices (e.g., cardiac pacemakers, implantable cardioverter/defibrillators, neurostimulators, aneurysm clips, un-documented stents, filters or micro coils, cochlear or otiologic implants, penile implants, undocumented heart valves, electronic medical implants, undocumented orthopedic im-plants or joints), body art or jewelry, and ferrous or metallic foreign objects from industrial or military injuries
  • Any given contraindications to ASV treatment:
    • severe bullous lung disease
    • pneumothorax or pneumomediastinum
    • pathologically low blood pressure, particularly if associated with intravascular volume de-pletion
    • dehydration
    • cerebrospinal fluid leak, recent cranial surgery, or trauma