NCT07658807 Aspirin Arterial Occlusive Diseases Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready landscape. This focused report examines NCT07658807—Evaluating Bu Yang Huanwu Decoction For Early Diabetic Vascular Disease—using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, Drug & Asset MCP for mechanism and development context, and Company & Deal Intelligence MCP for sponsor background. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.
MCP evidence snapshot: 20 July 2026; publication date: 20 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.
Why NCT07658807 is a hot trial to watch
Arterial Occlusive Diseases is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. NCT07658807 is notable because it evaluates Aspirin in a Phase 3 design while Ischemic Rest Pain: Persistent pain in the toes/forefoot at rest, typically nocturnal, worsened by elevation, relieved by dependency, often with pallor/coldness. Foot Ulcer: Ischemic skin breakdown/tissue necrosis in pressure areas (toes, heel, sole), with well-defined edges, dry/necrotic base, poor perfusion, and absence of significant inflammation. Assessment Method: Clinical evaluation by investigator at each scheduled visit. Confirmed by physical examination and documented photographically if applicable. serves as the main decision variable. The critical question is whether the protocol can convert its rationale into a clinically interpretable and operationally credible readout.
PatSnap Clinical Trials MCP makes protocol fields machine-readable, while the companion asset and organization servers add development-status, target and sponsor context.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07658807 |
| Official title | Evaluating Bu Yang Huanwu Decoction For Early Diabetic Vascular Disease |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | Aspirin, Hua Yu Wan Capsule |
| Sponsor | Xuanwu Hospital Capital Medical University |
| Collaborators | Peking University Third Hospital, Dongzhimen Hospital, Affiliated Hospital of Shandong University of TCM |
| Geography | China |
| Enrollment | 300 |
| Primary endpoint | Ischemic Rest Pain: Persistent pain in the toes/forefoot at rest, typically nocturnal, worsened by elevation, relieved by dependency, often with pallor/coldness. Foot Ulcer: Ischemic skin breakdown/tissue necrosis in pressure areas (toes, heel, sole), with well-defined edges, dry/necrotic base, poor perfusion, and absence of significant inflammation. Assessment Method: Clinical evaluation by investigator at each scheduled visit. Confirmed by physical examination and documented photographically if applicable. |
| Endpoint time frame | From enrollment to the end of treatment at 12 months |
| Primary completion / readout proxy | [object Object] |
Design and endpoint interpretation
The phase label is only the starting point. Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment of 300 participants across China shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Primary: Ischemic Rest Pain: Persistent pain in the toes/forefoot at rest, typically nocturnal, worsened by elevation, relieved by dependency, often with pallor/coldness. Foot Ulcer: Ischemic skin breakdown/tissue necrosis in pressure areas (toes, heel, sole), with well-defined edges, dry/necrotic base, poor perfusion, and absence of significant inflammation. Assessment Method: Clinical evaluation by investigator at each scheduled visit. Confirmed by physical examination and documented photographically if applicable. (From enrollment to the end of treatment at 12 months)
- Secondary: Composite primary outcome defined as the number of participants who develop either: (1) new-onset ischemic rest pain confirmed by investigator clinical assessment, or (2) ischemic foot ulcer confirmed by physical examination with photographic documentation when applicable, by Month 12. (From enrollment to the end of treatment at 12 months)
- Secondary: MACCE is defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. (From enrollment to the end of treatment at 12 months)
- Secondary: Number of participants who require inpatient hospitalization for any cause during the study period, as confirmed by hospital admission records or investigator documentation. Repeated hospitalizations in the same participant will be counted once unless otherwise specified in the statistical analysis plan. (From enrollment to the end of treatment at 12 months)
- Secondary: Number of participants who die from any cause during the study period, as confirmed by medical records, death certificates, hospital documentation, or investigator follow-up. Each participant will be counted once. (From enrollment to the end of treatment at 12 months)
Benchmark readouts in the surrounding field
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of RDX-002 on Postprandial Triglycerides in Patients Discontinuing the Glucagon-like Peptide-1 (GLP-1) Agonists, Semaglutide, or Tirzepatide for the Treatment of Obesity (Phase 2): Incremental Postprandial Triglycerides (TG)(Mean) = 43.81 percent change (Standard Deviation, 92.373); Incremental Postprandial Triglycerides (TG)(Mean) = -51.91 percent change (Standard Deviation, 72.293)
- A Phase II Study to Evaluate the Delay in Ovulation Following Oral Levonorgestrel Plus Meloxicam Compared to Placebo in Obese But Normal Menstruating Women (Phase 2): Interval From First Dose to Evidence of Ovulation.(Mean) = 2.67 Number of days (Standard Deviation, 1.53); Interval From First Dose to Evidence of Ovulation.(Mean) = 4.0 Number of days (Standard Deviation, 0)
- A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight (Phase 2): Percent Change From Baseline in Body Weight at Week 48(Least Squares Mean) = -0.4 percent change (Standard Error, 0.91); Percent Change From Baseline in Body Weight at Week 48(Least Squares Mean) = -9.4 percent change (Standard Error, 1.60)
These indexed results are contextual benchmarks, not direct head-to-head evidence. Population, treatment line, endpoint definitions, follow-up and analysis sets may differ. Their value is to clarify the type and magnitude of evidence already visible in the competitive landscape.
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Asset and sponsor context
Drug & Asset context: Aspirin (Approved; COX-1 x COX-2)
Company & Deal Intelligence context: Xuanwu Hospital Capital Medical University — China — http://www.xwhosp.com
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can decide whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Sequencing evidence: comparative data after the most relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter probability of success before a headline data release.
Bottom line
NCT07658807 is a focused lens on Arterial Occlusive Diseases development. Its value will be determined by whether Aspirin can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.
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