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A randomized controlled study to evaluate the Short-term anticoagulation strategy after TAVR for Prevention Subclinical leaflet thrombosis (SCOPE)

A randomized controlled study to evaluate the Short-term anticoagulation strategy after TAVR for Prevention Subclinical leaflet thrombosis (SCOPE)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087453
Enrollment
Unknown
Registered
2024-07-28
Start date
2024-08-08
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic stenosis

Interventions

Short-term anticoagulation group:Patients will receive anticoagulation therapy with rivaroxaban during the first month post-TAVR, with the specific dosage determined by the investigator based on the p
Standard single antiplatelet group:Patients will receive single antiplatelet therapy with aspirin 100 mg qd or clopidogrel 75 mg qd during the first month post-TAVR. Subsequent antithrombotic strategy

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years; 2. Symptomatic severe aortic valve stenosis successfully treated with TAVR; 3. The participant is able to understand the purpose of the trial, voluntarily agrees to participate, and provides written informed consent reviewed and approved by an ethics committee.

Exclusion criteria

Exclusion criteria: 1. Indications for long-term oral anticoagulant therapy (e.g., pulmonary embolism, deep vein thrombosis, atrial fibrillation etc.); 2. Indications for dual oral antiplatelet therapy (e.g., myocardial infarction, post-coronary revascularization etc.); 3. History of stroke; 4. Intolerance or allergy to rivaroxaban; 5. Presence of a condition at the time of enrollment that is expected to result in a life expectancy of less than 12 months; 6. Inability to complete the study or comply with the study requirements.

Design outcomes

Primary

MeasureTime frame
Hierarchical composite of cardiovascular death, first occurrence of myocardial infarction or stroke, first occurrence of life-threatening/disabling/major bleeding, >=50% reduced leaflet motion (RLM), and grade 3 or higher hypo-attenuated leaflet thickening (HALT);

Secondary

MeasureTime frame
All-cause Mortality;Cardiovascular Death;Myocardial Infarction;Stroke;Life-threatening or disabling bleeding;Major bleeding;Minor bleeding ;All bleeding;Grade 3 or higher Hypo-attenuated leaflet thickening (HALT);>=50% Reduced leaflet motion (RLM);Kansas City Cardiomyopathy Questionnaire score (KCCQ);

Countries

China

Contacts

Public ContactGuangyuan Song

Beijing Anzhen Hospital, Capital Medical University

songgy_fuwai@163.com+86 138 0112 0805

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026