REperfusion With P2Y12 Inhibitors in Addition to mEchanical thRombectomy for perFUsion Imaging Selected Acute Stroke patiEnts (REPERFUSE)

  • STATUS
    Recruiting
  • End date
    Jan 2, 2027
  • participants needed
    368
  • sponsor
    Fondation Ophtalmologique Adolphe de Rothschild
Updated on 9 April 2022

Summary

The main objective is to evaluate the efficacy of IV administration of the P2Y12 inhibitor (cangrelor) in addition to mecanich thrombectomy and WMD versus mecanich thrombectomy and WMD alone on the functional prognosis at 3 months, in patients with acute ischemic stroke eligible for mecanich thrombectomy on the basis of infusion imaging between 0 and 24 hours after the onset of symptoms.

Description

The emergent reperfusion of the ischemic penumbra is the goal of acute ischemic stroke (AIS) treatment. Mechanical thrombectomy (MT) may be proposed up to 6 hours and from 6 to 24 hours after stroke onset if multimodal imaging demonstrates the presence of a substantial ischemic penumbra.

Despite the major benefit associated with MT, more than half of patients will remain disabled at 3 months. The rate of complete reperfusion after MT appears to be a major factor affecting functional outcome. However, this rate of complete reperfusion is only achieved in 50 % of the patients due to, at least in part, distal microcirculatory impairment and or erratic emboli.

In coronary artery disease, new antiplatelet agents, with a very short half-life, such as P2Y12 inhibitors (P2Y12I), have been shown to reduce in-stent thrombosis, myocardial infarction and death. The IV route for P2Y12 inhibitors administration is adapted to the stroke population who has frequently dysphagia that prevents per os drug administration. In addition, the very short half-life of the drug is quite interesting for the management of hemorrhagic complications or emergent surgical interventions and early antithrombotic secondary prevention initiation.

Hpothesis: subgroup of patients treated from 0 to 24 hours after onset with a demonstrated ischemic penumbra on perfusion imaging, the administration of P2Y12I in addition to MT and best medical management (BMM) may increase reperfusion rates and improve functional outcome compared to MT with BMM alone.

Details
Condition Acute Ischemia
Treatment Cangrelor, Best Medical Management
Clinical Study IdentifierNCT04667078
SponsorFondation Ophtalmologique Adolphe de Rothschild
Last Modified on9 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age18 or older
Anterior circulation intracanial large artery occlusion proved on angioscanner or angio MRI
Symptoms onset < 24h at imaging
Indication for MT and fulfillment of the following brain imaging criteria
Perfusion imaging: An initial infarct volume (ischemic core on DWI or CTP calculated by the RAPID software) of less than 70 ml, a ratio between the critically hypoperfused lesion volume (calculated by RAPID with a TMax>6s) and initial infarct volume of 1.8 or more, and an absolute difference between those 2 volumes of 15 ml or more
OR (if perfusion imaging not available or uninterpretable)
CORE CLINICAL MISMATCH: Core calculated on DWI by RAPID, <25 mL if NIHSS 10-20 and <50 mL id NIHSS>20
Pre-stroke mRS ≤ 2
NIHSS ≥ 6

Exclusion Criteria

Contraindication to MT
Patient over 80 years old with >10 microbleeds on pre-treatment MRI
Pre-existing dependency with mRS ≥3
Tandem ICA-MCA occlusions requiring stenting
ASPECT<6 on NCCT or DWI-MRI
Known hypersensitivity to cangrelor or to any of the excipients (mannitol, sorbitol)
History of previous intracranial hemorrhage
Evidence of active bleeding or acute trauma (fracture) on examination
Recent surgery with a significant risk of bleeding
VKA oral anticoagulation with INR >1.7
Curative heparin or direct oral anticoagulants (DOACs) in previous 48 hours
Platelet count <100 000/ mm3
Women with childbearing potential (15-49 years old)
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