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A prospective randomised study evaluating the impact of post-procedural therapy, individually tailored to the patient’s resistance to antiplatelet agents, on treatment outcomes following interventional therapy for peripheral arterial disease

A prospective randomised study evaluating the impact of post-procedural therapy, individually tailored to the patient’s resistance to antiplatelet agents, on treatment outcomes following interventional therapy for peripheral arterial disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00039685
Enrollment
200
Registered
2026-03-20
Start date
2026-08-03
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

I70.20 I70.21 I70.22 I70.23 I70.24 I70.25

Interventions

Group 1: 100 patients: Multiplate-based strategy (test + adjustment if necessary) The Multiplate® analyser measures platelet aggregation in whole blood anticoagulated with hirudin by measuring changes
adjustments made only on the basis of clinical need, not laboratory test results)

Sponsors

Universitätsklinik für Allgemein-, Viszeral-, Gefäß- und Transplantationschirurgie Klinik für Gefäßchirurgie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients with symptomatic peripheral arterial disease (PAD), regardless of stage, who are receiving interventional treatment on the lower limbs - Follow-up of medical history, clinical status and Doppler ultrasound over a 12-month observation period, including medical history assessment, Doppler ultrasound of the legs with ABI measurement, and wound assessment according to the WIFI classification at 3, 6, 9 and 12 months - Baseline patient compliance - Guideline-based pharmacological treatment of symptomatic PAD with antiplatelet agents (APAs) and statins

Exclusion criteria

Exclusion criteria: - Patients receiving anticoagulant therapy - Intolerance to TAH - Dialysis patients - Patients taking NSAIDs - Patients with a known reduced response to TAH - Patients with liver dysfunction - Patients under the age of 18 - Pregnant women

Design outcomes

Primary

MeasureTime frame
primary, primary-assisted and secondary patency in interventional revascularisation—

Secondary

MeasureTime frame
- Quality of life assessed through a semi-quantitative survey of trends in subjective perception - Impact of side effects from changes or adjustments to medication (bleeding, skin reactions) - Major and minor amputations (MALE events) - MACE events - Improvement in wound condition in patients with stage IV peripheral arterial disease (PAD) based on the WifI classification—

Countries

Germany

Contacts

Public ContactUdo Barth

Universitätsklinik für Allgemein-, Viszeral-, Gefäß- und Transplantationschirurgie Klinik für Gefäßchirurgie

udo.barth@med.ovgu.de+49-391-67-15666

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026