Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke. The effect of periprocedural medication: acetylsalicylic acid, unfractionated heparin, both or neither

Phase 1

• Conditions: Acute ischemic stroke; MedDRA version: 21.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-001466-21-FR
• Lead Sponsor: Erasmus MC University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-09
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1500

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

- Pre-stroke disability which interferes with the assessment of functional
outcome at 90 days, i.e. mRS >2
- (Relative) contra-indications for ASA/unfractionated heparin, including: allergy, recent surgery, heparin induced thrombocytopenia, pregnancy
- INR exceeding 3.0
- Known hemorrhagic diathesis or known thrombopenia (<90^9/L)
- Treatment with IV alteplase despite the following contra-indications for
IV alteplase:
o cerebral infarction in the previous 6 weeks with residual neurological
deficit or signs of recent infarction on neuroimaging,
o previous intracerebral hemorrhage within the previous 3 months,
o INR exceeding 1.7,
o prior use of direct oral anticoagulant (DOAC),
- IV alteplase infusion >4.5 hours after symptom onset.
- therapeutic heparin use
- Participation in medical or surgical intervention trials other than
current (or MR ASAP / ARTEMIS)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified