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Reperfusion with P2Y12 inhibitors in addition to mechanical thrombectomy for perfusion imaging selected acute stroke patients : a multicentric randomized controlled trial
EU CTIS ID: 2024-516163-88-00
What this study is testing
Evaluate the efficacy of P2Y12 inhibitor (cangrelor) in addition to MT and BMM compared to MT and BMM alone on functional outcome at 3 months, in AIS patients selected on perfusion imaging between 0 and 24h after stroke onset.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 : 1. 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) : 2. 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) : 3. CORE CLINICAL MISMATCH according to the clinician evaluation
- Pre-stroke mRS ≤ 2
- NIHSS ≥ 6
You likely can't join if
- Contraindication to MT
- 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
See the full eligibility criteria
- 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 : 1. 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) : 2. 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) : 3. CORE CLINICAL MISMATCH according to the clinician evaluation
- Pre-stroke mRS ≤ 2
- NIHSS ≥ 6
- Contraindication to MT
- 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
- 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)
- History of previous intracranial hemorrhage
- Evidence of active bleeding or acute trauma (fracture) on examination
- Recent surgery with a significant risk of bleeding
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.