Multicenter Randomized CLinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands. The effect of periprocedural MEDication: heparin, antiplatelet agents, both or neither.

Multicenter Randomized CLinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands. The effect of periprocedural MEDication: heparin, antiplatelet agents, both or neither. - MR CLEAN - MED

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001466-21-NL

Enrollment

1500

Registered

2017-08-09

Start date

2017-10-19

Completion date

Unknown

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke MedDRA version: 20.0 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 100000013700

Interventions

Trade Name: Unfractionated heparin (generic) Product Name: heparin Pharmaceutical Form: Injection Trade Name: Aspegic (Acetylsalicylic acid) Product Name: Aspegic Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - a clinical diagnosis of acute ischemic stroke; - caused by intracranial large vessel occlusion of the anterior circulation (distal intracranial carotid artery or middle (M1/proximal M2) cerebral artery confirmed by neuro-imaging (CTA or MRA); - CT or MRI ruling out intracranial hemorrhage; - treatment possible (groin puncture) within 6 hours from symptom onset or last seen well; - a score of at least 2 on the NIH Stroke Scale; - age of 18 years or older; - written informed consent (deferred). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 750 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 750

Exclusion criteria

Exclusion criteria: - Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS >2 - Contra-indications for ASA/unfractionated heparin, for instance: allergy, recent surgery, heparin induced thrombocytopenia. - INR exceeding 3.0 - Thrombocyte count 4.5 hours after symptom onset.

Design outcomes

Primary

Measure	Time frame
Main Objective: Objective: To assess the effect of acetylsalicylic acid (ASA) and unfractionated heparin, alone, or in combination, in patients with AIS, who undergo IAT for a confirmed intracranial large vessel occlusion of the anterior circulation.;Secondary Objective: The secondary objective is to assess the safety and effect of unfractionated heparin and acetylsalicylic acid, alone, or in combination, on neurological outcome, revascularization and infarct size in patients who undergo intra-arterial treatment for AIS caused by a confirmed intracranial large vessel occlusion of the anterior circulation. The tertiary objectives are 1) to collect (waste) biomaterials and to analyze biofactors in blood samples with respect to their potential for treatment effect modification, 2) to collect and analyze data regarding the deferred consent procedure and its association with patient recall and satisfaction at three months from randomization, and 3) to study the efficiency of national IAT implementation. To this end, we aim to collect data (time delays and diagnostics) from each step in the acute stroke pathway as input parameters for a simulation model. This way we can study the regional set-up of the IAT organizational model.;Primary end point(s): The primary outcome is the score on the modified Rankin Scale (mRS) at 90 days (± 14 days).30 The mRS is the preferred disability parameter of clinical trials in stroke. The mRS is an ordinal hierarchical scale incorporating six categories from 0 up to and including 5, and describes the range of disability encountered post stroke. ‘Death’ is assigned a score of 6.;Timepoint(s) of evaluation of this end point: 90 days	—

Measure

Time frame

Main Objective: Objective: To assess the effect of acetylsalicylic acid (ASA) and unfractionated heparin, alone, or in combination, in patients with AIS, who undergo IAT for a confirmed intracranial large vessel occlusion of the anterior circulation.;Secondary Objective: The secondary objective is to assess the safety and effect of unfractionated heparin and acetylsalicylic acid, alone, or in combination, on neurological outcome, revascularization and infarct size in patients who undergo intra-arterial treatment for AIS caused by a confirmed intracranial large vessel occlusion of the anterior circulation. The tertiary objectives are 1) to collect (waste) biomaterials and to analyze biofactors in blood samples with respect to their potential for treatment effect modification, 2) to collect and analyze data regarding the deferred consent procedure and its association with patient recall and satisfaction at three months from randomization, and 3) to study the efficiency of national IAT implementation. To this end, we aim to collect data (time delays and diagnostics) from each step in the acute stroke pathway as input parameters for a simulation model. This way we can study the regional set-up of the IAT organizational model.;Primary end point(s): The primary outcome is the score on the modified Rankin Scale (mRS) at 90 days (± 14 days).30 The mRS is the preferred disability parameter of clinical trials in stroke. The mRS is an ordinal hierarchical scale incorporating six categories from 0 up to and including 5, and describes the range of disability encountered post stroke. ‘Death’ is assigned a score of 6.;Timepoint(s) of evaluation of this end point: 90 days

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Secondary

Measure	Time frame
Secondary end point(s): Secondary outcomes are the following: - Extended treatment in cerebral ischaemia (eTICI) score on final angiography of IAT (Table 2) - Recanalization rate at 24 hours, assessed with CTA - Score on the NIHSS at 24 hours and 5-7 days, or at discharge - Final infarct volume at 5-7 days, assessed with NCCT or MRI in a subset of 600 patients. Final infarct volume will be assessed with the use of an automated, validated algorithm. Infarct size at day 5-7 will be compared with plain CT and perfusion CT results (if available) at baseline. - Dichotomized mRS of 0-1 vs. 2-6 at 90 days (± 14 days) - Dichotomized mRS of 0-2 vs. 3-6 at 90 days (± 14 days) - Dichotomized mRS of 0-3 vs. 4-6 at 90 days (± 14 days) - Score on the EQ-5D-5L and Barthel index at 90 days (± 14 days) Safety endpoints are the following: - Intracerebral hemorrhage according to the Heidelberg Bleeding Classification - Symptomatic intracerebral hemorrhage (sICH) scored according to the Heidelberg Bleeding Classification, with the addition of sICH that led to death and that was identified as the predominant cause of the neurologic deterioration - Extracranial hemorrhages requiring transfusion or resulting in death - Embolization in new territory on angiography during IAT - Infarction in new territory within 5-7 days - Death from all causes within 90 days (+14 days);Timepoint(s) of evaluation of this end point: Mostly at 90 days	—

Measure

Time frame

Secondary end point(s): Secondary outcomes are the following: - Extended treatment in cerebral ischaemia (eTICI) score on final angiography of IAT (Table 2) - Recanalization rate at 24 hours, assessed with CTA - Score on the NIHSS at 24 hours and 5-7 days, or at discharge - Final infarct volume at 5-7 days, assessed with NCCT or MRI in a subset of 600 patients. Final infarct volume will be assessed with the use of an automated, validated algorithm. Infarct size at day 5-7 will be compared with plain CT and perfusion CT results (if available) at baseline. - Dichotomized mRS of 0-1 vs. 2-6 at 90 days (± 14 days) - Dichotomized mRS of 0-2 vs. 3-6 at 90 days (± 14 days) - Dichotomized mRS of 0-3 vs. 4-6 at 90 days (± 14 days) - Score on the EQ-5D-5L and Barthel index at 90 days (± 14 days) Safety endpoints are the following: - Intracerebral hemorrhage according to the Heidelberg Bleeding Classification - Symptomatic intracerebral hemorrhage (sICH) scored according to the Heidelberg Bleeding Classification, with the addition of sICH that led to death and that was identified as the predominant cause of the neurologic deterioration - Extracranial hemorrhages requiring transfusion or resulting in death - Embolization in new territory on angiography during IAT - Infarction in new territory within 5-7 days - Death from all causes within 90 days (+14 days);Timepoint(s) of evaluation of this end point: Mostly at 90 days

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Countries

Netherlands

Contacts

Public ContactDWJ Dippel, neurologist

Erasmus MC University Medical Center

d.dippel@erasmusmc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026