Stopping or continuing blood thinners after stroke at young age without a known cause: STOP trial

Phase 1

• Conditions: Stroke; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2024-513092-40-00
• Lead Sponsor: Stichting Radboud universitair medisch centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-09
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1316

Inclusion Criteria

First ever ischaemic stroke, or TIA with evidence of ischaemia on imaging, 3-10 years prior to study participation, Age 18-49 years at the time of TIA/ischaemic stroke, Cryptogenic aetiology, defined as no other aetiology after standard work-up according to national and international guidelines for young stroke (imaging of the brain (CT-scan or MRI-scan) and cervical arteries (CTA, MRA or carotid ultrasound), routine blood tests (complete blood count, erythrocyte sedimentation rate, CRP, antiphospholipid antibodies), ECG, at least 24 hours cardiac rhythm monitoring and transthoracic/transesophageal echocardiography).

Exclusion Criteria

History of MI, coronary revascularisation or documented peripheral arterial disease, Other indication for antiplatelet therapy, Indication for oral anticoagulants or low molecular weight heparin, Recurrent ischaemic event at any time after the index event, Any stenosis of intracranial or cervical artery at time of stroke, Two or more risk factors for atherosclerotic disease according to the following definitions: • arterial hypertension (treated or known blood pressure before stroke >140/90 mm Hg) • diabetes mellitus (treated or known blood fasting glucose >7 mmol/l) • current smoking (or smoking stopped within the last 6 months), • hypercholesterolaemia (treated or known low-density lipoprotein before the stroke >160 mg/dl or 4, mmol/l), Any condition that prevents long-term follow-up

Study & Design

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