Stopping or continuing platelet inhibitors after cryptogenic stroke at young age: STOP trial
Patients with cryptogenic stroke at the age of 18-49 years
Discontinuation of antiplatelet therapy. The intervention is the discontinuation of oral daily antiplatelet therapy (clopidogrel 75mg once daily or acetylsalicylic acid 80mg once daily, with or without dipyridamole 200mg twice daily). The comparator is the continuation of antiplatelet therapy according to standard care. There is no specific trial drug manufacturer. Patients will be randomly allocated 1:1 by an external web-based system to the intervention or comparator arm.
Current key inclusion criteria as of 06/08/2026: 1. First-ever ischaemic stroke, or TIA with evidence of ischaemia on imaging, 3-12 years before study participation 2. Age 18-49 years old at the time of TIA/ischaemic stroke 3. 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), ECG, at least 24 hours cardiac rhythm monitoring and transthoracic/transesophageal echocardiography). Previous key 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 stroke 3. 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).
1. History of MI, coronary revascularisation or documented peripheral arterial disease 2. Other indication for antiplatelet therapy 3. 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