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NCT02325466 · ClinicalTrials.gov registry record · Phase 3

Comparative Efficacy of Ticagrelor Versus Aspirin on Blood Viscosity in Peripheral Artery Disease Patients With Type 2 Diabetes

A Phase 3 study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
Phase 3
Development phase
70
Enrollment target

NCT02325466: Completed Phase 3 study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT02325466 is a Phase 3 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 70 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02325466, a Phase 3 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
Phase 3
Development phase
70 participants
Enrollment target

Study Summary

The hypothesis being that both aspirin-ticagrelor and ticagrelor monotherapy will be superior to aspirin monotherapy in the reduction of whole blood viscosity at the end of each 4 week treatment period. Study participants will be randomized into 3 groups, and each group will receive each of 3 treatments in the cross-over study. At the end of each individual 4 week treatment period the investigators will determine whether there are differences in low and high shear rate dependent viscosity and investigate the effect of the treatment on peripheral arterial blood flow using pulse volume recordings, ankle brachial index and toe pressures. Subjects will be eligible if they have ankle-brachial index less than or equal to 0.85, or if a patient's blood vessels are calcified, patients will have toe-brachial index less than or equal to 0.6 performed using continuous-wave Doppler.

Primary Outcome

Compare the effect of aspirin-ticagrelor and ticagrelor monotherapy with aspirin on blood viscosity from week 16 to baseline

Interventions

  • DRUG Aspirin
  • DRUG Ticagrelor
  • DRUG Ticagrelor Placebo
  • DRUG Aspirin Placebo

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2015-04
Est. Completion 2018-05-04
Phase Phase 3

What the finished NCT02325466 record still lists

NCT02325466 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 4 interventions - of which Aspirin is the first listed.

NCT02325466 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02325466 about?

NCT02325466 is a clinical study titled "Comparative Efficacy of Ticagrelor Versus Aspirin on Blood Viscosity in Peripheral Artery Disease Patients With Type 2 Diabetes". The hypothesis being that both aspirin-ticagrelor and ticagrelor monotherapy will be superior to aspirin monotherapy in the reduction of whole blood viscosity at the end of each 4 week treatment period. Study participants will be randomized into 3 groups, and each group will receive each of 3 treatm...

What is the current status of trial NCT02325466?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2015-04. Estimated completion is 2018-05-04.

What interventions are being tested in trial NCT02325466?

The interventions under investigation include: Aspirin (DRUG), Ticagrelor (DRUG), Ticagrelor Placebo (DRUG), Aspirin Placebo (DRUG).

Who is sponsoring clinical trial NCT02325466?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02325466's enrollment target sits among peer trials

70 1785th of 2000 higher than 208 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02325466, the US trial registry maintained by the National Library of Medicine. NCT02325466 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.