Status:
COMPLETED
Intraarterial Alteplase Versus Placebo After Mechanical Thrombectomy
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Fundació La Marató de TV3
Fundacion Clinic per a la Recerca Biomédica
Conditions:
Stroke, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Multicenter, randomized, placebo-controlled, double blind, phase 2b trial of acute stroke patients treated with mechanical thrombectomy (MT), in which two therapies are compared: rt-PA or placebo. All...
Detailed Description
The study objective is to evaluate whether rt-PA is safe and efficient as an add-on to mechanical thrombectomy in patients with acute ischemic stroke and complete or near-complete recanalization of a ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients with symptomatic large vessel occlusion (LVO) in the anterior, middle or posterior cerebral artery treated with MT resulting in an mTICI score 2b/3 at end of the procedure.. Patients with an mTICI score 2b/3 on the diagnostic cerebral angiography before the onset of MT are also eligible for the study.
- Estimated delay to onset of rescue intraarterial rt-PA administration \<24 hours from symptom onset, defined as the point in time the patient was last seen well
- No significant pre-stroke functional disability (modified Rankin scale 0-1), or mRS \>1 that according to the investigator is not related to neurological disease (i.e. amputation, blindness)
- Age ≥18
- ASPECTS \>6 on non-contrast CT (NCCT) scan or MRI if symptoms lasting \<4.5 hours or ASPECTS \>6 on CT-Perfusion (CTP) or DWI-MRI if symptoms \>4.5 \<24 hours.
- Informed consent obtained from patient or acceptable patient surrogate
- EXCLUSION CRITERIA:
- NIHSS score on admission \>25
- Contraindication to IV t-PA as per local national guidelines (except time to therapy)
- Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy during the first 24h
- Female who is pregnant or lactating or has a positive pregnancy test at time of admission
- Current participation in another investigation drug or device treatment study (except observational study i.e.: RACECAT or clinical trials not testing new medical devices or new drugs i.e.IMAGECAT)
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
- Known coagulopathy, INR \> 1.7 or use of novel anticoagulants \< 48h from symptom onset
- Platelets \< 50,000
- Renal Failure as defined by a serum creatinine \> 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate \[GFR\] \< 30
- Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason
- Any hemorrhage on CT/MRI
- Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
- Suspicion of aortic dissection
- Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol
- History of life threatening allergy (more than rash) to contrast medium
- SBP \>185 mmHg or DBP \>110 mmHg refractory to treatment
- Serious, advanced, terminal illness with anticipated life expectancy \< 6 months
- Pre-existing neurological or psychiatric disease that would confound evaluation
- Presumed vasculitis or septic embolization
- Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas)
Exclusion
Key Trial Info
Start Date :
December 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT03876119
Start Date
December 5 2018
End Date
May 31 2021
Last Update
May 20 2022
Active Locations (7)
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1
Germans Trias i Pujol Hospital
Badalona, Spain
2
Hospital Clinic of Barcelona
Barcelona, Spain, 08036
3
Hospital del Mar
Barcelona, Spain, 08036
4
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Spain