Summary
Caffeine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Peripheral Artery Disease (PAD) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Peripheral Artery Disease (PAD). ClinicalTrials.gov lists 6 registered trials linking Caffeine to Peripheral Artery Disease (PAD): 1 is currently recruiting; 1 is active or not yet recruiting; 2 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00388128). The largest enrolment is 3000 participants (NCT06541691). Registration activity spans 2006 to 2026. The literature layer holds 1 publication for this pair: 1 clinical trial publication. The dated items are from 2010. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Peripheral Arterial Disease ranks 292 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Progressive disease; spontaneous improvement rare; limb ischaemia worsens in 25-30% over 5 years; major adverse limb events (MALE) in 10-15%/year in advanced PAD; major amputation in 5-10% at 5 years without revascularisation.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 38.0 (trials 16.0, literature 2.0, tier 15, approved bonus 5.0) |
| Registered trials | 6 total: 1 recruiting, 1 active / not yet recruiting, 2 completed, 2 other |
| Linked publications | 1 (1 clinical trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | inhibitor; inhibitor |
| Data sources | DGIdb |
| Linked via biomarker / target | ADORA2A |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01483898 | An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI) 2012 | completed | Phase 3 | 41 |
| NCT00388128 | Caffeine and Intermittent Claudication 2006 | completed | Phase 3 | 80 |
| NCT07622485 | In-Hospital Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease (INSPIRE) 2026 | not yet recruiting | Not applicable | 1,500 |
| NCT06541691 | Coated or Chewable Aspirin and a Hybrid Strategy to Mitigate Adverse Effects of Air Pollution in Stable Atherosclerotic Disease 2024 | recruiting | Not applicable | 3,000 |
| NCT04054232 | Evaluation of an Electronic Health Record-based Screening Tool for Peripheral Artery Disease 2023 | status unknown | Not applicable | 50 |
| NCT06261606 | Feasibility of a Multifaceted Program to Reduce Cardiovascular Complications of Air Pollution 2024 | status unknown | Not applicable | 50 |
Published literature
- Clinical trial publication Randomized double-blind placebo-controlled crossover study of caffeine in patients with intermittent claudicationMomsen AH, Jensen MB, Norager CB et al. · The British journal of surgery · 2010 · PMID 20629111
Mechanism and notes
Recorded mechanism or class: inhibitor; inhibitor.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ADORA2A. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Caffeine approved for Peripheral Artery Disease (PAD)?
Caffeine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Peripheral Artery Disease (PAD) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Peripheral Artery Disease (PAD). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Caffeine in clinical trials for Peripheral Artery Disease (PAD)?
ClinicalTrials.gov lists 6 registered trials linking Caffeine to Peripheral Artery Disease (PAD): 1 is currently recruiting; 1 is active or not yet recruiting; 2 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00388128). The largest enrolment is 3000 participants (NCT06541691). Registration activity spans 2006 to 2026.
What does the evidence show for Caffeine in Peripheral Artery Disease (PAD)?
Caffeine has 2 completed trials and 1 linked publication for Peripheral Artery Disease (PAD). Completed trials may or may not have posted results; follow the NCT links to check. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ADORA2A. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.