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

Not Applicable

• Conditions: Patients with cryptogenic stroke at the age of 18-49 years; Circulatory System

• Registration Number: ISRCTN96178713
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-09-17
• Last Update Posted: 30 September 2024
• Study Completion: 2032-11-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1316

Inclusion Criteria

1. First ever ischaemic stroke, or TIA with evidence of ischaemia on imaging, 3-10 years before study participation 2. Age 18-49 years old at the time of TIA/ischaemic stroke3. 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

1. History of MI, coronary revascularisation or documented peripheral arterial disease2. Other indication for antiplatelet therapy3. Indication for oral anticoagulants or low molecular weight heparin 4. Recurrent ischaemic event at any time after the index event 5. Any stenosis of intracranial or cervical artery at time of stroke 6. Two or more risk factors for atherosclerotic disease prior to the index event, according to the following definitions:6.1. Arterial hypertension (treated or known blood pressure before stroke >140/90 mm Hg) 6.2. Diabetes mellitus (treated or known blood fasting glucose >7 mmol/l) 6.3. Current smoking (or smoking stopped within the last 6 months)6.4. Hypercholesterolaemia (treated or known low-density lipoprotein before the stroke >160 mg/dl or 4, mmol/l) 7. Any condition that prevents long-term follow-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary efficacy outcome:1. A composite endpoint of major vascular events, defined as TIA with imaging confirmation, stroke, myocardial infarction, or death from vascular causes measured using a digital questionnaire or telephone follow-up and verified with medical records with annual follow-up for five yearsPrimary safety outcome:2. Major bleeding, according to the International Society for Thrombosis and Haemostasis criteria, measured using a digital questionnaire or telephone follow-up and verified with medical records with annual follow-up for five years

Secondary Outcome Measures

Name	Time	Method
The following secondary outcome measures are assessed using digital questionnaires or telephone follow-up with annual follow-up for five years:1. Disability measured using the modified Ranking Scale2. Quality of life measured using EQ-5D-5L3. All cause mortality