Rationale and design of the Arterial Disease Multiple Intervention Trial (ADMIT) pilot study.

Area of Science:

• Cardiovascular Medicine
• Clinical Trial Design
• Pharmacotherapy

Background:

• Peripheral arterial disease (PAD) affects a significant population, particularly older adults, with limited secondary prevention trials.
• Intermittent claudication is a common symptom of PAD, with incidence increasing with age.
• Current research lacks specific trials focusing on comprehensive interventions for PAD patients.

Purpose of the Study:

• To determine the feasibility of recruiting PAD patients for a complex medication regimen.
• To assess the efficacy and safety of various treatments including HDL-raising, LDL-lowering, antioxidant, and antithrombotic therapies.
• To evaluate patient adherence to a multifaceted drug regimen and its impact on functional status and quality of life.

Main Methods:

• A double-blind, randomized pilot trial involving 468 participants with documented PAD.
• A 2x2x2 factorial design was employed to test three interventions: lipid modification (HDL-raising and LDL-lowering), antioxidant therapy, and antithrombotic therapy.
• Noninvasive ankle-brachial index was used for PAD identification; adherence was measured by pill count.

Main Results:

• The study successfully recruited PAD patients, demonstrating feasibility for complex intervention trials.
• Efficacy and safety data for individual and combined therapies were collected.
• Adherence rates and the proportion of patients achieving target lipid and coagulation levels were assessed.

Conclusions:

• This pilot trial established the feasibility of recruiting PAD patients for intensive multi-drug intervention studies.
• The study provides a foundation for future, larger-scale secondary prevention trials in PAD.
• Findings inform the design of interventions targeting lipid profiles, oxidative stress, and thrombosis in PAD management.