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

Study acronym: REPERFUSE
StatusSuspended
PhasePhase 3
Started2022-03-02
View on ClinicalTrials.gov ↗
Why the trial stopped
The study was terminated prematurely due to futility based on a pre-specified interim analysis, awaiting for the last visit of the last patient

Amendment history

2026-09-26
critical
Recruitment suspended: The study was terminated prematurely due to futility based on a pre-specified interim analysis, awaiting for the l...
Primary completion moved earlier: 2030-03-01 → 2026-12-21
Completion moved earlier: 2030-09-01 → 2027-12-21
2026-02-27
minor
Study Status, Contacts/Locations v12
Primary completion date2026-03-02→2030-03-01
Completion date2027-01-02→2030-09-01
Study sitescontacts updated at 1 of 13 sites
2026-01-16
minor
Study Status, Oversight, Eligibility, Contacts/Locations v11
Primary completion date2026-06-02→2026-03-02
Study sites9→13
Eligibility criteria+195 characters
[...] evaluation Pre-stroke mRS ≤ 2 NIHSS ≥ 6 Exclusion Criteria:- Contraindication to MT Contraindication to MT Patient over 80 years old with >10 m [...] n or direct oral anticoagulants (DOACs) in previous 48 hours with specific DOAC dosage ≥50 ng/ml and abnormal thrombin time for patients on dabigatran or abnormal specific anti-Xa activity for patients on apixaban, edoxaban, or rivaroxaban Platelet count <100 000/ mm3 WomenWoman of childbearing age without a pregnancy test or with childbearinga potentialpositive (15-49serum yearspregnancy old)test Patient benefiting from a legal protection Non-membersh [...] [...]
2025-06-19
minor
Study Status, Oversight v10
Re-verified, no change to tracked fields
2024-02-15
minor
Study Status, Contacts/Locations v9
Study sitesdetails revised at 3 of 9 sites
Show 8 earlier versions
2023-11-13
minor
Study Status, Study Description, Eligibility v8
Eligibility criteria+451 characters
Inclusion Criteria: Age18Age 18 or older Anterior circulation intracanial large artery occlusion isolated (Intracranial ICA and/or MCA) proved on angioscannerCTA or angio MRIMRA. Symptoms onset < 24h at imaging Indication for MT and fulf [...] MISMATCH: Core calculated on DWI by RAPID, <25 mL if NIHSS 106-20 and <50 mL idif NIHSS>20 OR (if RAPID results are not considered reliable by the clinician) : CORE CLINICAL MISMATCH according to the clinician evaluation Pre-stroke mRS ≤ 2 NIHSS ≥ 6 Exclusion Criteria:- Contraindication to MT Contraindication to MT Patient over 80 years old with >10 microbleed [...] [...]
Study description+1 characters
[...] s and early antithrombotic secondary prevention initiation. HpothesisHypothesis: subgroup of patients treated from 0 to 24 hours after onse [...]
2023-06-12
minor
Study Status, Contacts/Locations v7
Primary completion date2024-01-02→2026-06-02
Study sites8→9
2022-03-11
notable
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-01-15→2024-01-02
Completion date2027-01-15→2027-01-02
Start dateestimated 2022-03-15→confirmed 2022-03-02
Study sites0→8
Eligibility criteria+543 characters
Inclusion Criteria: 18 yearsAge18 or older Anterior circulation intracanial large artery occlusion (Intracranialproved on angioscanner or angio MRI. Symptoms onset < 24h at imaging Indication for thrombectomyMT 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 betw [...] Exclusion Criteria:- Contraindica [...] [...]
2022-02-24
minor
Study Status v5
Start date2022-01-15→2022-03-15
2021-12-23
minor
Study Status, Sponsor/Collaborators, Eligibility, Contacts/Locations v4
Primary completion date2023-09-15→2024-01-15
Completion date2026-09-15→2027-01-15
Start date2021-09-15→2022-01-15
Eligibility criteria-787 characters
Inclusion Criteria: 18 years or older OcclusionAnterior ofcirculation aintracanial large vesselartery of the intrâcranial anterior circulationocclusion (carotid T and/or ACM) on Angioscanner or Angio MRI.Intracranial Time ofSymptoms onset of< symptoms24h less than or equal to 24 hours (at theimaging Indication time of medical imaging) mecanichfor thrombectomy indication and onefulfillment of the following twobrain imaging criteria : In perfusion imaging: initial volume of infarction less than 70 ml, a ratio between the volume of ischaemic tissue and the initial volume of infarction of 1.8 or m [...] [...]
Collaborators+26 characters
Ministry of Health, France
2021-06-22
minor
Study Status, Oversight, Eligibility v3
Eligibility criteria+554 characters
Inclusion Criteria: Indication18 foryears MTor basedolder Occlusion of a large vessel of the intrâcranial anterior circulation (carotid T and/or ACM) on Angioscanner or Angio MRI. Time of onset of symptoms less than or equal to 24 hours (at the time of medical imaging) mecanich thrombectomy indication and one of the following two imaging criteria : In perfusion imaging with: An initial infarct volume (ischemicof core)infarction less than 70 ml A, a ratio between the ischemicvolume volumeof ischaemic tissue and the initial infarctvolume volumeof infarction of 1.8 or more An, and an absolute dif [...] [...]
2021-04-21
minor
Study Status v2
Primary completion date2023-03-15→2023-09-15
Completion date2026-03-15→2026-09-15
Start date2021-03-15→2021-09-15
2021-01-21
minor
Study Status, Study Description, Contacts/Locations v1
Primary completion date2022-01-15→2023-03-15
Completion date2023-01-15→2026-03-15
Start date2021-01-15→2021-03-15
Study descriptionrevised
[...] on initiation. Hpothesis: subgroup of patients treated from 60 to 24 hours after onset with a demonstrated ischemic penumb [...]
2020-12-09
minor
Original filing
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.
Trial Details
NCT Number NCT04667078
Lead Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Collaborators: Ministry of Health, France
Conditions Acute Ischemia
Enrollment 368 participants
Start Date 2022-03-02
Primary Completion 2026-12-21 (estimated)
Study Completion 2027-12-21 (estimated)
Updated on ClinicalTrials.gov 2026-09-25