2024-516163-88-00招募中4 期
Reperfusion with P2Y12 inhibitors in addition to mechanical thrombectomy for perfusion imaging selected acute stroke patients : a multicentric randomized controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 368
- 试验地点
- 12
- 主要终点
- Favorable functional outcome defined by a modified Rankin Scale (mRS) score ≤ 2 at 3 months.
研究概览
简要总结
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.
研究设计
- 分配方式
- Randomized
- 主要目的
- Open-label, Phase Iii, Multicenter, Randomized, Controlled Study In Two Balanced Parallel Groups.
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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) :
- •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
排除标准
- •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
结局指标
主要结局
Favorable functional outcome defined by a modified Rankin Scale (mRS) score ≤ 2 at 3 months.
Favorable functional outcome defined by a modified Rankin Scale (mRS) score ≤ 2 at 3 months.
次要结局
- mRS shift analysis at 3 months.
- a. Rate of near or complete reperfusion at end of treatment defined by modified treatment in cerebral infarction (mTICI) score 2c or 3. b. Rate of successful reperfusion at end of treatment defined by modified treatment in cerebral infarction (mTICI) score of 2b or 2c or 3.
- Change in NIHSS from baseline to 24 hours after treatment.
- Volume assessed by the ASPECTS score (Assessment in Acute Stroke Alberta Stroke Program Early CT) at 24-36 hours.
- Rate of all-cause mortality at 3 months.
- Rate of symptomatic intracranial hemorrhage according the Heidelberg definition associated to at least 4 points worsening in NIHSS at 24-36h after treatment.
- Rate of any intracranial hemorrhage according the Heidelberg definition at 24-36h after treatment.
研究者
Clinical Research Department
Scientific
Fondation A De Rothschild
研究点 (12)
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