Predicted inability to swallow study medication
Women who are pregnant or breastfeeding
Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding such as a large infarct volume (per investigator discretion) or uncontrolled hypertension
Hemorrhage, intracranial tumor, arteritis, large vessel dissection, AVM, or other pathology that could account for index symptoms must be excluded by CT or MRI interpreted locally
Symptomatic carotid stenosis or intracranial artery stenosis for which endarterectomy or angioplasty is planned within 90 days
Any condition for which chronic anticoagulation is indicated and expected to be initiated (eg, NVAF, DVT, PE)
Requirement for continued use of DAPT for >21 days or non-aspirin antiplatelet therapy or anticoagulant for another medical condition (eg, prophylaxis for venous thromboembolism)
History of hemorrhage into the brain, subarachnoid hemorrhage, subdural hematoma, or spinal cord hemorrhage except CMB and minor hemorrhagic transformation of prior infarct manifesting as scattered petechiae (HI1 according to Heidelberg classification)35
History of clinically meaningful hepatic disease and/or clinically significant abnormal liver function
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Any of the following laboratory results outside of the ranges specified below prior to study treatment administration, confirmed by repeat:
Intracranial tumor (except meningioma, which is permitted) or aneurysm > 5 mm or AVM (except treated aneurysm without history of intracranial bleed, which is permitted)
History of ESRD with eGFR <15 mL/min/1.73 m2 or requiring dialysis
Planned use of anticoagulants, including warfarin or other vitamin K antagonists, oral thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, unfractionated heparin, and LMWH, with the exception of heparin or LMWH used to maintain patency of indwelling catheters
Anticipated concomitant chronic (>14 days) use of systemic NSAIDs; NSAID use (including COX-2 inhibitors) prior to randomization is allowed
Use of combined P-gp and strong CYP3A4 inhibitors or combined P-gp and strong CYP3A4 inducers in the 7 days prior to randomization, or the need for ongoing treatment with concomitant oral or intravenous therapy with combined P-gp and strong CYP3A4 inhibitors or combined P-gp and strong CYP3A4 inducers during the study
Planned concomitant use of omeprazole or esomeprazole after randomization for the duration of clopidogrel treatment (eg, H2 blockers [except cimetidine] and other PPIs are allowed)
History of or any of the following findings on 12-lead ECG prior to study drug administration: atrial fibrillation, atrial flutter, complete heart block, or Mobitz II second-degree heart block
Known SARS-CoV-2 infection within 4 weeks prior to screening
