Acute IschemiaPhase 3REPERFUSENCT04667078
REperfusion With P2Y12 Inhibitors in Addition to mEchanical thRombectomy for perFUsion Imaging Selected Acute Stroke patiEnts
A Phase 3 study testing Cangrelor and best medical management in people with Acute Ischemia, run by Fondation Ophtalmologique Adolphe de Rothschild at 13 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemia
- What is being tested?
- Cangrelor and best medical management
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 13 sitesFrance
- Study dates
- 2 Mar 2022to 21 Dec 2027
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Anterior circulation intracanial large artery occlusion isolated (Intracranial ICA and/or MCA) proved on CTA or MRA.
- 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) :
Show all 11Show fewer
- CORE CLINICAL MISMATCH: Core calculated on DWI by RAPID, <25 mL if NIHSS 6-20 and <50 mL if 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
Who cannot join
- Contraindication to MT
- Patient over 80 years old with >10 microbleeds on pre-treatment MRI
- Pre-existing dependency with mRS ≥3.
- Known 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)
Show all 17Show fewer
- 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 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
- Woman of childbearing age without a pregnancy test or with a positive serum pregnancy test
- Patient benefiting from a legal protection
- Non-membership of a national insurance scheme
- Opposition of the patient or (in case of inclusion as a matter of urgency) of the trustworthy person
- Participation in another study regarding AIS care interfering with this study.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CHU de Besançon
Besançon, 25030
Hôpital Pellegrin (CHU de Bordeaux)
Bordeaux
Hospices civils de Lyon, Hôpital Pierre Wertheimer
Bron, 69500
Hôpital Salengro (CHU Lille)
Lille, 59037
Hôpital Dupuytren (CHU Limoges)
Limoges, 87000
CHU La Timone
Marseille, 13005
Hôpital Central (CHU de Nancy)
Nancy, 54000
Hôpital Lariboisière AP-HP
Paris, 75010
Hôpital Pitié-Salpêtrière AP-HP
Paris, 75013
Hôpital Fondation A de Rothschild
Paris, 75019
CHU de Strasbourg
Strasbourg, 67200
Hôpital Foch
Suresnes, 92150
Hôpital Purpan (CHU de Toulouse)
Toulouse, 31300
About this study
Official title: REperfusion With P2Y12 Inhibitors in Addition to mEchanical thRombectomy for perFUsion Imaging Selected Acute Stroke patiEnts (REPERFUSE)
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.
Read the detailed 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.
Hypothesis: 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.
- Conditions
- Acute Ischemia
- Being tested
- Cangrelor, best medical management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CangrelorDrug
administration of cangrolor by iv befor thrombectomy
best medical managementOther
used yhe best medical management
| Study group | Role | What they receive |
|---|---|---|
| Cangrelor group | Experimental | treated by P2Y12 inhibitor (cangrelor) in addition to MT and BMM. The dose of cangrelor will be started with a 30 micrograms/kg IV bolus over 1 minute right after randomization and before MT. The bolus will be immediately followed with 4 micrograms/kg/min IV infusion for the duration of MT up to 4 hours. Cangrelor infusion will be stopped at the end of the MT procedure and will not go further 4 hours. Transition to oral antiplatelet therapy will be possible 1 hour after cangrelor infusion discontinuation. No other anti-thrombotic drug is authorized during cangrelor infusion. MT technique choice is left to the investigator decision. Receives: Drug: Cangrelor |
| Best medical management group | Active comparator | treated by BMM associated to MT. Anti-thrombotic including alteplase are authorized if they follow the recommendations of the international guidelines. If alteplase infusion is given, no other anti-thrombotic drug is allowed for the following 24 hours. MT technique choice is left to the choice of the investigator. Receives: Other: best medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favorable functional evaluation at 3 month for patients with acute ischemic strocke treated by cangrelor.
The favorable functional outcome at 3 month will be evaluated using a modified Rankin Scale (mRS). The scale runs from 0 to 6, running from perfect health without symptoms to death (0: no symptoms, 3: Moderate disability. Requires some help, but able to walk unassisted, 6: Dead).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start2 Mar 2022
- Primary completion21 Dec 2026 (estimated)
- Study completion21 Dec 2027 (estimated)
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute IschemiaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- experimental group will be treated by P2Y12 inhibitor (cangrelor) in addition to MT and BMM
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667078
- Sponsor's protocol ID
- MMI_2020_35
- Acronym
- REPERFUSE
- Status last verified
- Sep 2026
- First submitted
- 24 Nov 2020
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REperfusion With P2Y12 Inhibitors in Addition to mEchanical thRombectomy for perFUsion Imaging Selected Acute Stroke patiEnts (REPERFUSE)
- ClinicalTrials.gov ID
- NCT04667078
- Acronym / sponsor ID
- REPERFUSE / MMI_2020_35
- Conditions
- Acute Ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason 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
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- Ministry of Health, France
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 21 Dec 2026 (estimated)
- Study completion
- 21 Dec 2027 (estimated)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Hypothesis: 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- experimental group will be treated by P2Y12 inhibitor (cangrelor) in addition to MT and BMM
| Arm | Type | Receives |
|---|---|---|
| Cangrelor group | Experimental | Drug: Cangrelortreated by P2Y12 inhibitor (cangrelor) in addition to MT and BMM. The dose of cangrelor will be started with a 30 micrograms/kg IV bolus over 1 minute right after randomization and before MT. The bolus will be immediately followed with 4 micrograms/kg/min IV infusion for the duration of MT up to 4 hours. Cangrelor infusion will be stopped at the end of the MT procedure and will not go further 4 hours. Transition to oral antiplatelet therapy will be possible 1 hour after cangrelor infusion discontinuation. No other anti-thrombotic drug is authorized during cangrelor infusion. MT technique choice is left to the investigator decision. |
| Best medical management group | Active comparator | Other: best medical managementtreated by BMM associated to MT. Anti-thrombotic including alteplase are authorized if they follow the recommendations of the international guidelines. If alteplase infusion is given, no other anti-thrombotic drug is allowed for the following 24 hours. MT technique choice is left to the choice of the investigator. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 or older
- Anterior circulation intracanial large artery occlusion isolated (Intracranial ICA and/or MCA) proved on CTA or MRA.
- Symptoms onset < 24h at imaging
- Indication for MT and fulfillment of the following brain imaging criteria :
- Pre-stroke mRS ≤ 2
Key exclusion criteria (17 listed)
- Contraindication to MT
- Patient over 80 years old with >10 microbleeds on pre-treatment MRI
- Pre-existing dependency with mRS ≥3.
- Known tandem ICA-MCA occlusions requiring stenting
- ASPECT<6 on NCCT or DWI-MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cangreloradministration of cangrolor by iv befor thrombectomy | Drug | Cangrelor group |
| best medical managementused yhe best medical management | Other | Best medical management group |
Primary outcome
Favorable functional evaluation at 3 month for patients with acute ischemic strocke treated by cangrelor.
Time frame: 3 months
The favorable functional outcome at 3 month will be evaluated using a modified Rankin Scale (mRS). The scale runs from 0 to 6, running from perfect health without symptoms to death (0: no symptoms, 3: Moderate disability. Requires some help, but able to walk unassisted, 6: Dead).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Ischemia
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cangrelor and best medical management in people with Acute Ischemia, run by Fondation Ophtalmologique Adolphe de Rothschild at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable functional evaluation at 3 month for patients with acute ischemic strocke treated by cangrelor. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.